Clinical trial NCT02235727: Safety and Tolerability of GBR 900 in a Single Ascending Dose Study in Healthy Subjects
Official title: A Phase 1, Double-Blind, Randomised, Placebo-Controlled, Study to Evaluate the Safety and Pharmacokinetics of GBR 900 in Adult Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Glenmark Pharmaceuticals Ltd. India
Sponsor class: INDUSTRY
Collaborators: name: Glenmark Pharmaceuticals S.A.
First posted: 2014-09-10
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: A Single Dose Study of GBR 900 in Healthy Volunteers.

Detailed description: This is a phase I study of GBR 900 in healthy volunteers. The purposes of this study are to look at safety, how well the study drug is tolerated, how much of the study drug gets into the blood stream, and how long it takes the body to get rid of it when given to humans. Information about any side effects that may occur will also be collected. Each participant will remain in the study for approximately 3.5 months. This study is for research purposes only and is not intended to treat any medical condition.

Eligibility criteria: Inclusion Criteria:

1. Body mass index (BMI) within the range 18.5-32 kg/m2 (inclusive); weight must be ≥ 50 kg.
2. Men and women aged between 18 and 55 years (inclusive). Female subjects must be of non-child-bearing potential
3. Subjects who are otherwise healthy and free from clinically significant illness or disease as determined by medical history, vital signs, physical examinations, and other tests performed by the investigator.

Exclusion Criteria:

1. Subjects with a history of neuropathy or otherwise present with risk factors for neurological toxicity like chronic alcoholism or clinically significant neurological (e.g. dementia, cognitive decline, seizure disorders) or psychiatric disorders.
2. Subjects with a recent history of live vaccination within the past 3 month or presence of active infections within the previous month.
3. Subjects with previous exposure to antibody therapies or administration of immunoglobulins (Ig) within 6 months of randomization.
4. Subjects with a history of or presence of inflammatory disease or rheumatological diseases or joint diseases including OA or any undiagnosed pain in joints.
5. Subjects with a current and/or recent history of arthralgia or a history of fibromyalgia, migraine, neuralgia, or systemic painful conditions, or medical or arthritic conditions or any undiagnosed pain or systemic inflammatory disorders.
6. Any evidence of organ dysfunction or any clinically significant deviation from the normal in history, physical or neurological determinations or investigations or has a clinical condition or receiving therapy that, in the opinion of the Investigator, would make the subjects unsuitable for study.

Primary outcomes:
measure: Drug related adverse events (AEs) or any serious AEs
timeFrame: 71 days
Secondary outcomes:
measure: Maximum Concentration (Cmax) of single ascending doses of GBR 900 in adult healthy volunteers
timeFrame: Pre-dose and post-dose at planned multiple time points from 2 hours to 168 hours and from day 15 until day 71
measure: Area Under Curve [(AUC (0-∞) and AUC (0-t)] of single ascending doses of GBR 900 in adult healthy volunteers
timeFrame: Pre-dose and post-dose at planned multiple time points from 2 hours to 168 hours and from day 15 until day 71
measure: Half life (t1/2) of single ascending doses of GBR 900 in adult healthy volunteers
timeFrame: Pre-dose and post-dose at planned multiple time points from 2 hours to 168 hours and from day 15 until day 71
measure: Immunogenicity of GBR 900
timeFrame: Pre-dose and at day 29, day 43, and day 71
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Covance Clinical Research Unit Ltd
state: Yorkshire
Study officials:
affiliation: Covance
name: Jim Bush, MBChB, PhD, MRCS
role: PRINCIPAL_INVESTIGATOR
References: