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

Glenmark Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: GBR 900

Study type: Interventional

Funder types: Industry

Identifiers

NCT02235727

2013-005480-31 (EudraCT Number)

GBR 900-101

Details and patient eligibility

About

A Single Dose Study of GBR 900 in Healthy Volunteers.

Full 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.

Enrollment: 37 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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37 participants in 2 patient groups, including a placebo group

GBR 900

Experimental group

Description:

Test treatment GBR 900

Treatment:

Drug: GBR 900

Placebo

Placebo Comparator group

Description:

Placebo Treatment

Treatment:

Drug: Placebo