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Safety and Tolerability of GBR 900 in a Single Ascending Dose Study in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT02235727
Recruitment Status : Completed
First Posted : September 10, 2014
Last Update Posted : January 24, 2017
Sponsor:
Collaborator:
Glenmark Pharmaceuticals S.A.
Information provided by (Responsible Party):
Glenmark Pharmaceuticals Ltd. India

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

Condition or disease Intervention/treatment Phase
Healthy Drug: GBR 900 Drug: Placebo Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
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 Start Date : July 2014
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Arm Intervention/treatment
Experimental: GBR 900
Test treatment GBR 900
Drug: GBR 900
Placebo Comparator: Placebo
Placebo Treatment
Drug: Placebo



Primary Outcome Measures :
  1. Drug related adverse events (AEs) or any serious AEs [ Time Frame: 71 days ]
    All treatment - emergent adverse events (TEAEs), occuring during the study, in terms of nature, onset, duration, severity, relationship and outcome of adverse events and serious adverse events in adult healthy volunteers from baseline to day 71.


Secondary Outcome Measures :
  1. Maximum Concentration (Cmax) of single ascending doses of GBR 900 in adult healthy volunteers [ Time Frame: Pre-dose and post-dose at planned multiple time points from 2 hours to 168 hours and from day 15 until day 71 ]
  2. Area Under Curve [(AUC (0-∞) and AUC (0-t)] of single ascending doses of GBR 900 in adult healthy volunteers [ Time Frame: Pre-dose and post-dose at planned multiple time points from 2 hours to 168 hours and from day 15 until day 71 ]
  3. Half life (t1/2) of single ascending doses of GBR 900 in adult healthy volunteers [ Time Frame: Pre-dose and post-dose at planned multiple time points from 2 hours to 168 hours and from day 15 until day 71 ]
  4. Immunogenicity of GBR 900 [ Time Frame: Pre-dose and at day 29, day 43, and day 71 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02235727


Locations
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United Kingdom
Covance Clinical Research Unit Ltd
Leeds, Yorkshire, United Kingdom, LS29LH
Sponsors and Collaborators
Glenmark Pharmaceuticals Ltd. India
Glenmark Pharmaceuticals S.A.
Investigators
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Principal Investigator: Jim Bush, MBChB, PhD, MRCS Covance

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Responsible Party: Glenmark Pharmaceuticals Ltd. India
ClinicalTrials.gov Identifier: NCT02235727     History of Changes
Other Study ID Numbers: GBR 900-101
2013-005480-31 ( EudraCT Number )
First Posted: September 10, 2014    Key Record Dates
Last Update Posted: January 24, 2017
Last Verified: January 2017