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

Healthy Clinical Trial

Official title:

A Phase 1, Double-Blind, Randomised, Placebo-Controlled, Study to Evaluate the Safety and Pharmacokinetics of GBR 900 in Adult Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02235727
• Other study ID #: GBR 900-101
• Secondary ID: 2013-005480-31
• Status: Completed
• Phase: Phase 1
• First received: August 7, 2014
• Last updated: January 23, 2017
• Start date: July 2014
• Est. completion date: November 2016

Study information

• Verified date: January 2017
• Source: Glenmark Pharmaceuticals Ltd. India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A Single Dose Study of GBR 900 in Healthy Volunteers.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• GBR 900

• Placebo

Locations

Country	Name	City	State
United Kingdom	Covance Clinical Research Unit Ltd	Leeds	Yorkshire

Sponsors (2)

Lead Sponsor	Collaborator
Glenmark Pharmaceuticals Ltd. India	Glenmark Pharmaceuticals S.A.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Drug related adverse events (AEs) or any serious AEs	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.	71 days
Secondary	Maximum Concentration (Cmax) of single ascending doses of GBR 900 in adult healthy volunteers		Pre-dose and post-dose at planned multiple time points from 2 hours to 168 hours and from day 15 until day 71
Secondary	Area Under Curve [(AUC (0-8) and AUC (0-t)] of single ascending doses of GBR 900 in adult healthy volunteers		Pre-dose and post-dose at planned multiple time points from 2 hours to 168 hours and from day 15 until day 71
Secondary	Half life (t1/2) of single ascending doses of GBR 900 in adult healthy volunteers		Pre-dose and post-dose at planned multiple time points from 2 hours to 168 hours and from day 15 until day 71
Secondary	Immunogenicity of GBR 900		Pre-dose and at day 29, day 43, and day 71