Status:
COMPLETED
Safety and Tolerability of GBR 900 in a Single Ascending Dose Study in Healthy Subjects
Lead Sponsor:
Glenmark Pharmaceuticals Ltd. India
Collaborating Sponsors:
Glenmark Pharmaceuticals S.A.
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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,...
Eligibility Criteria
Inclusion
- Body mass index (BMI) within the range 18.5-32 kg/m2 (inclusive); weight must be ≥ 50 kg.
- Men and women aged between 18 and 55 years (inclusive). Female subjects must be of non-child-bearing potential
- 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
- 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.
- Subjects with a recent history of live vaccination within the past 3 month or presence of active infections within the previous month.
- Subjects with previous exposure to antibody therapies or administration of immunoglobulins (Ig) within 6 months of randomization.
- Subjects with a history of or presence of inflammatory disease or rheumatological diseases or joint diseases including OA or any undiagnosed pain in joints.
- 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.
- 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.
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2016
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT02235727
Start Date
July 1 2014
End Date
November 1 2016
Last Update
January 24 2017
Active Locations (1)
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1
Covance Clinical Research Unit Ltd
Leeds, Yorkshire, United Kingdom, LS29LH