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

NCT02235727 | Completed Phase 1

• 2 other identifiers: GBR 900-1012013-005480-31
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

A Single Dose Study of GBR 900 in Healthy Volunteers.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

• Area Under Curve [(AUC (0-∞) 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

• 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

• Immunogenicity of GBR 900

  Pre-dose and at day 29, day 43, and day 71

Study Arms (2)

GBR 900

EXPERIMENTAL

Test treatment GBR 900

Drug: GBR 900

Placebo

PLACEBO COMPARATOR

Placebo Treatment

Drug: Placebo

Interventions

GBR 900 DRUG

GBR 900

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Glenmark Pharmaceuticals Ltd. India: lead
• Glenmark Pharmaceuticals S.A.: collaborator

Study Sites (1)

Covance Clinical Research Unit Ltd

Leeds, Yorkshire, LS29LH, United Kingdom

Location

Study Officials

• Jim Bush, MBChB, PhD, MRCS

  Covance

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2014
• First Posted: September 10, 2014
• Study Start: July 1, 2014
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: January 24, 2017

Record last verified: 2017-01

Locations

GB (1)