This study is the first study with GSK2982772, a receptor-interacting protein-1 (RIP1) kinase
inhibitor, in subjects with moderate to severe RA who are currently being treated with
disease modifying anti-rheumatic drugs (DMARDs). The primary objective of the study is to
investigate the safety and tolerability of repeat oral doses of GSK2982772 in subjects with
moderate to severe RA. In addition to the PK, a number of experimental and clinical endpoints
will be employed to obtain information on the PD, and preliminary efficacy in subjects with
active RA. Although no formal hypothesis will be tested, these endpoints will enable a
broader understanding of the mechanism of action and potential for clinical efficacy of
GSK2982772 in RA. After a screening period of up to 30 days, approximately 24 subjects will
be randomized to receive either GSK2982772 or placebo for 84 days (12 weeks), followed by a
follow-up period (28 days). The total duration of participation in the study will be
approximately 20 weeks from screening to the last study visit.
-
Number of subjects with adverse event (AE) and serious adverse event (SAE) as a measure of safety and tolerability.
[Time Frame: Up to Day 113]
An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment will be categorized as SAE.
-
Number of subjects with abnormal clinical chemistry parameters as a measure of safety and tolerability.
[Time Frame: Up to Day 113]
Blood samples will be collected at Day 1, Day 8, Day 15, Day 29, Day 43, Day 57, Day 71, Day 85, and at follow-up visit.
-
Number of subjects with abnormal hematology parameters as a measure of safety and tolerability.
[Time Frame: Up to Day 113]
Blood samples will be collected at Day 1, Day 8, Day 15, Day 29, Day 43, Day 57, Day 71, Day 85, and at follow-up visit.
-
Number of subjects with abnormal urinalysis parameters as a measure of safety and tolerability.
[Time Frame: Up to Day 113]
Blood samples will be collected at Day 1, Day 8, Day 15, Day 43, Day 85, and at follow-up visit.
-
Number of subjects with abnormal systolic blood pressure assessment (SBP) and diastolic blood pressure (DBP) assessment as a measure of safety and tolerability.
[Time Frame: Up to Day 113]
Systolic and diastolic blood pressure will be measured on each day in semi-supine position after 5 minutes rest.
-
Number of subjects with abnormal heart rate assessment as a measure of safety and tolerability.
[Time Frame: Up to Day 113]
Heart rate will be measured on each day in semi-supine position after 5 minutes rest.
-
Number of subjects with abnormal respiratory rate assessment as a measure of safety and tolerability.
[Time Frame: Up to Day 113]
Respiratory rate will be measured on each day in semi-supine position after 5 minutes rest.
-
Number of subjects with abnormal body temperature assessment as a measure of safety and tolerability.
[Time Frame: Up to Day 113]
Body temperature will be measured on each day in semi-supine position after 5 minutes rest.
-
Number of subjects with abnormal electrocardiogram (ECG) assessment as a measure of safety and tolerability.
[Time Frame: Up to Day 113]
12- lead ECG will be measured on each day using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QT interval corrected for heart rate according to either Bazett's formula (QTcB), or QT interval corrected for heart rate according to Fridericia's formula (QTcF) intervals. ECG will be measured in semi-supine or supine position after 5 minutes rest.
-
Pre-dose plasma concentration of GSK2982772
[Time Frame: Pre-dose on Day 8 and Day 43]
Blood samples will be collected on Day 8 and Day 43 for determining pre-dose plasma concentration of GSK2982772.
-
Post-dose plasma concentration of GSK2982772
[Time Frame: 1, 2, 4 and 6 hours post-dose on Day 1, 8 and 43]
Blood samples will be collected on Day 1, Day 8 and Day 43 for determining post-dose plasma concentrations of GSK2982772
-
Trough plasma concentration of GSK2982772
[Time Frame: Day 85]
Blood samples will be collected on Day 85 for determining trough concentration of GSK2982772 .
-
Change from Baseline in C-Reactive Protein (CRP)
[Time Frame: Baseline (Day 1) and up to Day 85 (Week 12)]
Blood samples will be collected on Day 1, Day 43, and Day 85
-
Change from Baseline in Interleukin 6 (IL6)
[Time Frame: Baseline (Day 1) and up to Day 85 (Week 12)]
Blood samples will be collected on Day 1, Day 43, and Day 85
-
Change from Baseline in Matrix metalloproteinase-1 (MMP-1), MMP-3, and MMP-13
[Time Frame: Baseline (Day 1) and up to Day 85 (Week 12)]
Blood samples will be collected on Day 1, Day 43, and Day 85
-
Change from Baseline in tissue inhibitor of metalloproteinases-1 (TIMP-1)
[Time Frame: Baseline (Day 1) and up to Day 85 (Week 12)]
Blood samples will be collected on Day 1, Day 43, and Day 85
-
Change from Baseline in monocyte chemo attractant protein-1 (MCP-1)
[Time Frame: Baseline (Day 1) and up to Day 85 (Week 12)]
Blood samples will be collected on Day 1, Day 43, and Day 85
-
Change from Baseline in migration inhibitory factor (MIF)
[Time Frame: Baseline (Day 1) and up to Day 85 (Week 12)]
Blood samples will be collected on Day 1, Day 43, and Day 85
-
Change from Baseline in Myeloid-related Protein 8/14 (MRP8/14)
[Time Frame: Baseline (Day 1) and up to Day 85 (Week 12)]
Blood samples will be collected on Day 1, Day 43, and Day 85
-
Change from Baseline in bone erosions by OMERACT-RAMRIS (Outcome Measures in Rheumatology, Rheumatoid Arthritis Magnetic Resonance Image Scoring System) scoring system
[Time Frame: Baseline (Day 1) and up to Day 85 (Week 12)]
Magnetic resonance imaging (MRI) parameters will be measured in the most affected hand/wrist on Day 1, Day 43, and Day 85. Bone erosions will be assessed by OMERACT-RAMRIS scoring system
-
Change from Baseline in bone erosions by the RAMRIQ (Rheumatoid arthritis MRI quantitative) scoring system
[Time Frame: Baseline (Day 1) and up to Day 85 (Week 12)]
MRI parameters will be measured in the most affected hand/wrist on Day 1, Day 43, and Day 85. Bone erosions will be assessed by the RAMRIQ scoring system
-
Change from Baseline in bone erosions by the modified CARLOS (Cartilage Loss Scoring System)
[Time Frame: Baseline (Day 1) and up to Day 85 (Week 12)]
MRI parameters will be measured in the most affected hand/wrist on Day 1, Day 43, and Day 85. Bone erosions will be assessed by the modified CARLOS
-
Change from Baseline in synovitis by OMERACT-RAMRIS scoring system
[Time Frame: Baseline (Day 1) and up to Day 85 (Week 12)]
MRI parameters will be measured by in the most affected hand/wrist on Day 1, Day 43, and Day 85. Synovitis will be assessed by OMERACT-RAMRIS scoring system
-
Change from Baseline in synovitis by the RAMRIQ scoring system
[Time Frame: Baseline (Day 1) and up to Day 85 (Week 12)]
MRI parameters will be measured in the most affected hand/wrist on Day 1, Day 43, and Day 85. Synovitis will be assessed by the RAMRIQ scoring system
-
Change from Baseline in synovitis by the modified CARLOS
[Time Frame: Baseline (Day 1) and up to Day 85 (Week 12)]
MRI parameters will be measured in the most affected hand/wrist on Day 1, Day 43, and Day 85. Synovitis will be assessed by the modified CARLOS
-
Change from Baseline in bone edema by OMERACT-RAMRIS scoring system
[Time Frame: Baseline (Day 1) and up to Day 85 (Week 12)]
MRI parameters will be measured in the most affected hand/wrist on Day 1, Day 43, and Day 85. Bone edema will be assessed by OMERACT-RAMRIS scoring system
-
Change from Baseline in bone edema by the RAMRIQ scoring system
[Time Frame: Baseline (Day 1) and up to Day 85 (Week 12)]
MRI parameters will be measured in the most affected hand/wrist on Day 1, Day 43, and Day 85. Bone edema will be assessed by the RAMRIQ scoring system
-
Change from Baseline in bone edema by the modified CARLOS
[Time Frame: Baseline (Day 1) and up to Day 85 (Week 12)]
MRI parameters will be measured in the most affected hand/wrist on Day 1, Day 43, and Day 85. Bone edema will be assessed by the modified CARLOS
-
Change from Baseline in joint space narrowing by OMERACT-RAMRIS scoring system
[Time Frame: Baseline (Day 1) and up to Day 85 (Week 12)]
MRI parameters will be measured in the most affected hand/wrist on Day 1, Day 43, and Day 85. Joint space narrowing will be assessed by OMERACT-RAMRIS scoring system
-
Change from Baseline in joint space narrowing by the RAMRIQ scoring system
[Time Frame: Baseline (Day 1) and up to Day 85 (Week 12)]
MRI parameters will be measured in the most affected hand/wrist on Day 1, Day 43, and Day 85. Joint space narrowing will be assessed by the RAMRIQ scoring system
-
Change from Baseline in joint space narrowing by the modified CARLOS
[Time Frame: Baseline (Day 1) and up to Day 85 (Week 12)]
MRI parameters will be measured in the most affected hand/wrist on Day 1, Day 43, and Day 85. Joint space narrowing will be assessed by the modified CARLOS
-
Change from Baseline in exchange rate (Ktrans)
[Time Frame: Baseline (Day 1) and up to Day 85 (Week 12)]
Ktrans will be measured by dynamic contrast enhanced (DCE)-MRI in most affected hand/wrist on Day 1, Day 43, and Day 85
-
Change from Baseline in interstitial volume (Ve)
[Time Frame: Baseline (Day 1) and up to Day 85 (Week 12)]
Ve will be measured by DCE-MRI in most affected hand/wrist on Day 1, Day 43, and Day 85
-
Change from Baseline in plasma volume (Vp)
[Time Frame: Baseline (Day 1) and up to Day 85 (Week 12)]
Vp will be measured by DCE-MRI in most affected hand/wrist on Day 1, Day 43, and Day 85
-
Change from Baseline in initial rate of enhancement (IRE)
[Time Frame: Baseline (Day 1) and up to Day 85 (Week 12)]
IRE will be measured by DCE-MRI in most affected hand/wrist on Day 1, Day 43, and Day 85
-
Change from Baseline in maximal signal intensity enhancement (ME)
[Time Frame: Baseline (Day 1) and up to Day 85 (Week 12)]
ME will be measured by DCE-MRI in most affected hand/wrist on Day 1, Day 43, and Day 85
-
Change from Baseline in joint volume
[Time Frame: Baseline (Day 1) and up to Day 85 (Week 12)]
Joint volume will be measured by DCE-MRI in most affected hand/wrist on Day 1, Day 43, and Day 85
-
Change from Baseline in enhancing volume
[Time Frame: Baseline (Day 1) and up to Day 85 (Week 12)]
Enhancing volume will be measured by DCE-MRI in most affected hand/wrist on Day 1, Day 43, and Day 85
-
Change from Baseline in Disease Activity Score (DAS) 28-C-Reactive Protein (CRP) scores.
[Time Frame: Baseline (Day 1) and up to Day 85 (Week 12)]
The component of DAS28 assessment include tender/painful joint count (28), swollen joint count (28), CRP, and patient global assessment of disease (PtGA)
-
Proportion of subjects achieving categorical DAS28-CRP response
[Time Frame: Baseline (Day 1) and up to Day 85 (Week 12)]
Proportion of subjects achieving categorical DAS28-CRP response will be measured as moderate/good European League Against Rheumatism (EULAR) response at each assessment time point.
-
Proportion of subjects achieving categorical American college of rhumatology20/50/70 (ACR20/50/70) response.
[Time Frame: Baseline (Day 1) up to Day 85 (Week 12)]
The component of ACR assessment include tender/painful joint count (28), swollen joint count (28), patients assessment of joint pain, PtGA, Physician's Global Assessment of Disease (PGA), CRP and disability index of the healthy assessment questionnaire (HAQ-DI)
-
Pre-dose Plasma concentrations of Methotrexate (MTX)
[Time Frame: Baseline (Day 1) up to Day 85 (Week 12)]
Blood samples will be collected at Day 1, Day 8, and Day 43
| Brief Title | Safety and Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD) and Efficacy of Repeat Doses of GSK2982772 in Subjects With Moderate to Severe Rheumatoid Arthritis (RA) |
| Official Title | A Multicenter, Randomized, Double-blind (Sponsor-unblinded), Placebo-controlled Study to Investigate the Safety and Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of GSK2982772 in Subjects With Moderate to Severe Rheumatoid Arthritis |
| Brief Summary |
This study is the first study with GSK2982772, a receptor-interacting protein-1 (RIP1) kinase
inhibitor, in subjects with moderate to severe RA who are currently being treated with
disease modifying anti-rheumatic drugs (DMARDs). The primary objective of the study is to
investigate the safety and tolerability of repeat oral doses of GSK2982772 in subjects with
moderate to severe RA. In addition to the PK, a number of experimental and clinical endpoints
will be employed to obtain information on the PD, and preliminary efficacy in subjects with
active RA. Although no formal hypothesis will be tested, these endpoints will enable a
broader understanding of the mechanism of action and potential for clinical efficacy of
GSK2982772 in RA. After a screening period of up to 30 days, approximately 24 subjects will
be randomized to receive either GSK2982772 or placebo for 84 days (12 weeks), followed by a
follow-up period (28 days). The total duration of participation in the study will be
approximately 20 weeks from screening to the last study visit.
|
| Detailed Description | |
| Study Type | Interventional |
| Study Phase | Phase 2 |
| Estimated Enrollment | 32 |
| Allocation | Randomized |
| Interventional Model | Parallel Assignment |
| Masking | Double |
| Primary Purpose | Treatment |
| Conditions |
Arthritis, Rheumatoid
|
| Target Follow-Up Duration | N/A |
| Biospecimen: |
N/A
|
| Sampling Method | N/A |
| Study Population | N/A |
| Intervention |
Drug:
GSK2982772 60 mg
GSK2982772 is available as a 30 mg white to almost white, round film coated tablet which will be administered as two tablets thrice daily as directed.
Drug:
Placebo
Placebo is available as a white to almost white, round film coated tablet which will be administered as two tablets thrice daily as directed.
|
| Study Groups/Cohorts |
Subjects receiving GSK2982772 60 mg
Enrolled subjects will receive GSK2982772 60 mg thrice daily (approximately 8 hours apart) for 84 days.
Subjects receiving Placebo
Enrolled subjects will receive placebo thrice daily (approximately 8 hours apart) for 84 days.
|
| Study Arms |
Experimental
Subjects receiving GSK2982772 60 mg
Enrolled subjects will receive GSK2982772 60 mg thrice daily (approximately 8 hours apart) for 84 days.
Drug :
GSK2982772 60 mg
GSK2982772 is available as a 30 mg white to almost white, round film coated tablet which will be administered as two tablets thrice daily as directed.
Experimental
Subjects receiving Placebo
Enrolled subjects will receive placebo thrice daily (approximately 8 hours apart) for 84 days.
Drug :
Placebo
Placebo is available as a white to almost white, round film coated tablet which will be administered as two tablets thrice daily as directed.
|
| Recruitment Status: | Active, not recruiting |
| Enrollment | 32 |
| Completion Date | September 17, 2018 |
| Eligibility Criteria: |
Inclusion Criteria:
- Between 18 and 75 years of age inclusive, at the time of signing the informed consent.
- Subjects that do not have any medical conditions, other than moderate to severe RA,
that in the opinion of the Investigator put the subject at unacceptable risk or
interfere with study assessments or integrity of the data. These medical conditions
should be stable at the time of screening and are expected to remain stable for the
duration of the study.
- Subject has had a confirmed diagnosis of rheumatoid arthritis according to the revised
2010 ACR-EULAR classification criteria.
- Disease duration of >=12 weeks (time from onset of patient-reported symptoms of either
pain or stiffness or swelling in hands, feet or wrists) at screening.
- Swollen joint count of >=4 (28-joint count) and tender joint count >=4 (28-joint
count) at screening.
- Subject has a DAS28 CRP disease activity score of >= 3.2 and CRP >= 5.0 mg/liter (L)
(>=4.76 nanomole (nmol)/L) at screening.
- Subject must have received at least 12 weeks of non-biologic DMARD monotherapy or
MTX/DMARD combination therapy prior to screening and must be on stable dose throughout
the study.
- Subject is naive to any biological therapies for RA or subject may have had previous
exposure to a single anti-tumor necrosis factor (TNF) biologic agent which was
discontinued for reasons other than primary non-response more than 8 weeks (or 5 half
lives whichever is longer) from first dose.
- For subjects who have consented to synovial joint biopsy:
• Subject has an involved knee, wrist, or ankle suitable for biopsy, as assessed by a
rheumatologist at screening.
- A body mass index (BMI) within range of 18.5 - 35 kilogram/meter^2 (Kg/m^2)
(inclusive) at screening.
- Male and female subjects Males: Male subjects with female partners of child bearing
potential must comply with the contraception requirements specified in the protocol.
Females: A female subject is eligible to participate if she is not pregnant (as confirmed
by a negative serum human chorionic gonadotropin [HCG] test), not lactating, and at least
one of the following conditions applies:
- Non-reproductive potential as defined as pre-menopausal females with either documented
tubal ligation or Documented hysteroscopic tubal occlusion procedure with follow-up
confirmation of bilateral tubal occlusion or Hysterectomy or Documented Bilateral
Oophorectomy. For Postmenopausal females as 12 months of spontaneous amenorrhea in
questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH)
and estradiol levels consistent with menopause. Females on hormone replacement therapy
(HRT) and whose menopausal status is in doubt will be required to use one of the
highly effective contraception methods if they wish to continue their HRT during the
study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal
status prior to study enrollment..
- Reproductive potential and agrees to follow one of the options listed in the Modified
List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive
Potential (FRP) from 30 days prior to the first dose of study medication and until at
least 30 days after the last dose of study medication and completion of the follow-up
visit.
- The Investigator is responsible for ensuring that subjects understand how to
properly use these methods of contraception.
- Capable of giving signed informed consent as described in the protocol which
includes compliance with the requirements and restrictions listed in the consent
form and in this protocol.
Exclusion Criteria:
- Subject with a positive anti-double stranded deoxyribonucleic acid (DNA [anti-dsDNA])
and confirmed diagnosis of systemic lupus erythematosus (SLE).
- Subject with current history of Suicidal Ideation Behavior (SIB) as measured using the
Columbia Suicide Severity Rating Scale (C-SSRS) or a history of attempted suicide.
- An active infection, or a history of infections as follows:
- Hospitalization for treatment of infection within 60 days before first dose (Day
1).
- Currently on any suppressive therapy for a chronic infection (such as
pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster and atypical
mycobacteria).
- Use of parenteral (intravenous [IV] or intramuscular) antibiotics
(antibacterials, antivirals, antifungals, or antiparasitic agents) for an
infection within 60 days before first dose.
- A history of opportunistic infections within 1 year of screening (e.g.
pneumocystis jirovecii, cytomegalovirus [CMV] pneumonitis, aspergillosis). This
does not include infections that may occur in immunocompetent individuals, such
as fungal nail infections or vaginal candidiasis, unless it is of an unusual
severity or recurrent nature.
- Recurrent or chronic infection or other active infection that, in the opinion of
the Investigator might cause this study to be detrimental to the patient.
- History of Tuberculosis (TB), irrespective of treatment status.
- A positive diagnostic TB test at screening defined as a positive QuantiFERON-TB
Gold test or T-spot test. In cases where the QuantiFERON or T-spot test is
indeterminate, the subject may have the test repeated once, but they will not be
eligible for the study unless the second test is negative. In cases where the
QuantiFERON or T-spot test is positive, but a locally-read follow up chest x-ray,
shows no evidence of current or previous pulmonary tuberculosis, the subject may
be eligible for the study at the discretion of the Investigator and GSK Medical
Monitor.
- Electrocardiogram QT interval corrected for heart rate (QTc) > 450 milliseconds (msec)
or QTc > 480 msec for subjects with bundle branch block at screening.
The QTc is the QT interval corrected for heart rate according to either Bazett's formula
(QTcB), Fridericia's formula (QTcF), or another method, machine or manual over read. The
specific formula that will be used to determine eligibility and discontinuation for an
individual subject should be determined and documented prior to initiation of the study. In
other words, several different formulae cannot be used to calculate the QTc for an
individual subject and then the lowest QTc value used to include or discontinue the subject
from the trial. For purposes of data analysis, QTcB, QTcF, another QT correction formula,
or a composite of available values of QTc will be used.
- Alanine aminotransferase (ALT) >2x upper limit of normal (ULN) and bilirubin >1.5xULN
(isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct
bilirubin <35 percent) at screening.
- Current active or chronic history of liver or biliary disease (with the exception of
Gilbert's syndrome or asymptomatic gallstones).
- Current or history of renal disease or estimated glomerular filtration rate (GFR) by
Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI) calculation <60
milliliter (mL)/minute (min)/1.73 m^2 at screening.
- Hereditary or acquired immunodeficiency disorder, including immunoglobulin deficiency.
- A major organ transplant (e.g., heart, lung, kidney, liver) or hematopoietic stem
cell/marrow transplant.
- Any planned surgical procedures including surgical joint procedures (e.g.,
intra-articular, tendon sheath, or bursal corticosteroid injections) during the study.
- A history of malignant neoplasm within the last 5 years, except for adequately treated
non-metastatic cancers of the skin (basal or squamous cell) or carcinoma in situ of
the uterine cervix that has been fully treated and shows no evidence of recurrence.
- Has undergone surgery including synovectomy or arthroplasty on the joint chosen for
biopsy and/or magnetic resonance imaging (MRI).
- The subject has a history of any other joint disease other than RA at the knee, wrist
or ankle joint chosen for biopsy and/or MRI (e.g., gout, pseudogout, osteoarthritis).
- Has undergone intra-articular corticosteroid injection, arthrocentesis or synovial
biopsy on any joint within 6 weeks of screening.
- A known allergy to lidocaine or other local anesthetics (only applies to subjects who
consent for synovial biopsy procedures).
- Contraindication to MRI scanning (as assessed by local MRI safety questionnaire) which
includes but are not limited to:
- Intracranial aneurysm clips (except SugitaTM) or other metallic objects,
- History of intra-orbital metal fragments that have not been removed by a medical
professional.
- Pacemakers or other implanted cardiac rhythm management devices and non-MR
compatible heart valves,
- Inner ear implants,
- History of claustrophobia which may impact participation.
- The subject has received treatment with the prohibited therapies listed in the
protocol, or changes to those treatments, within the prescribed timeframe.
• Other medications (including vitamins, herbal and dietary supplements) will be
considered on a case-by-case basis, and will be allowed if in the opinion of the
Investigator the medication will not interfere with the study procedures or compromise
subject safety.
- History of alcohol or drug abuse that would interfere with the ability to comply with
the study.
- History of sensitivity to any of the study treatments, or components thereof or a
history of drug or other allergy that, in the opinion of the Investigator or Medical
Monitor, contraindicates their participation.
- Received a live or attenuated vaccine within 30 days of randomization or plan to
receive a vaccination during the study until half-lives (or 2 days) plus 30 days after
receiving GSK2982772.
- Contraindication to gadolinium contrast agent in accordance with local guidelines.
- The subject has participated in a clinical trial and has received an investigational
product within 30 days or 5 half-lives, whichever is longer before the first dose of
study medication, or plans to take part in another clinical trial at the same time as
participating in this clinical trial.
- Hemoglobin <9 grams/deciliter (g/dL);hematocrit <30 percent, white blood cell count
=<3,000/millimeter^3 (mm^3) (=<3.0 x 10^9/L); platelet count =<100,000/ microliter
(μL) (=<100 x 10^9/L); absolute neutrophil count =<1.5 x 10^9/L at screening. For
subjects recruited in Germany: hemoglobin <11 g/dL at screening.
- Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test
result at screening or within 3 months prior to first dose of study treatment. As
potential for and magnitude of immunosuppression with this compound is unknown,
subjects with presence of hepatitis B core antibody (HBcAb) should be excluded.
- A positive serology for human immunodeficiency virus (HIV) 1 or 2 at screening.
- Where participation in the study would result in donation of blood or blood products
in excess of 500 mL within 3 months.
- Exposure to more than 4 investigational medicinal products within 12 months prior to
the first dose.
|
| Gender | All |
| Age | 18 Years to 75 Years |
| Accepts Healthy Volunteers | No |
| Contacts |
Not Available
|
| Listed Location Countries |
Germany
Italy
Poland
Russian Federation
Spain
United Kingdom
|