Safety Study of GNbAC1 Monoclonal Antibody in Healthy Male Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2015-08-31

Brief Summary

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In this clinical study, the safety and tolerability of GNbAC1 as a treatment for MS patients will be evaluated in healthy male volunteers.

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Detailed Description

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The monoclonal antibody, GNbAC1, targets the envelope protein (Env) of the human endogenous retrovirus (HERV), also called multiple sclerosis associated retrovirus (MSRV), which is considered as a critical factor in the development of multiple sclerosis.

This study will assess the pharmacokinetics, safety and tolerability of GNbAC1 following single ascending doses (6, 18, and 36 mg/kg) administered via IV infusion.

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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6 mg/kg GNbAC1

7 subjects randomized 5:2 active treatment:placebo

Group Type ACTIVE_COMPARATOR

GNbAC1

Intervention Type DRUG

Single dose of IMP, IV infusion

18 mg/kg GNbAC1

7 subjects randomized 5:2 active treatment:placebo

Group Type ACTIVE_COMPARATOR

GNbAC1

Intervention Type DRUG

Single dose of IMP, IV infusion

36 mg/kg GNbAC1

7 subjects randomized 5:2 active treatment:placebo

Group Type ACTIVE_COMPARATOR

GNbAC1

Intervention Type DRUG

Single dose of IMP, IV infusion

Interventions

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GNbAC1

Single dose of IMP, IV infusion

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male subjects as determined by past medical history, physical examination, vital signs, ECG and laboratory tests at Screening and confirmed at Day -1 who have signed the informed consent.
* Aged from 18 to 55 years, both inclusive.

Exclusion Criteria

* History of serious adverse reactions or hypersensitivity to any drug.
* Presence or history of any allergy requiring acute or chronic treatment (seasonal allergic rhinitis that requires no treatment may be tolerated).
* Need of any prescription medication within 15 days prior to the administration of the study drug and/or non-prescription medication within 7 days prior to the administration of the study drug or anticipated need for any concomitant medication during the study.
* Participation in a clinical trial during the previous 3 months, i.e. from completion of the previous trial to the planned first administration of the current trial.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes