Safety Study of GNbAC1 Monoclonal Antibody in Healthy Male Volunteers

Sponsor

GeNeuro Innovation SAS (Industry)

Overall Status

Completed

CT.gov ID

NCT02452996

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

5.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: GNbAC1	Phase 1

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

21 participants

Allocation:

Randomized

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Randomised, Double-Blind, Placebo Controlled, Single Ascending Doses Study With GNbAC1 in Healthy Male Volunteers

Study Start Date :

Apr 1, 2015

Actual Primary Completion Date :

Aug 1, 2015

Actual Study Completion Date :

Aug 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 6 mg/kg GNbAC1 7 subjects randomized 5:2 active treatment:placebo	Drug: GNbAC1 Single dose of IMP, IV infusion
Active Comparator: 18 mg/kg GNbAC1 7 subjects randomized 5:2 active treatment:placebo	Drug: GNbAC1 Single dose of IMP, IV infusion
Active Comparator: 36 mg/kg GNbAC1 7 subjects randomized 5:2 active treatment:placebo	Drug: GNbAC1 Single dose of IMP, IV infusion

Arm

Intervention/Treatment

Active Comparator: 6 mg/kg GNbAC1

7 subjects randomized 5:2 active treatment:placebo

Drug: GNbAC1

Single dose of IMP, IV infusion

Active Comparator: 18 mg/kg GNbAC1

7 subjects randomized 5:2 active treatment:placebo

Drug: GNbAC1

Single dose of IMP, IV infusion

Active Comparator: 36 mg/kg GNbAC1

7 subjects randomized 5:2 active treatment:placebo

Drug: GNbAC1

Single dose of IMP, IV infusion

Outcome Measures

Primary Outcome Measures

safety and tolerability of single ascending doses of GNbAC1 in healthy male subjects [57 days]
AE, SAE, vital signs, ECG, clinical laboratory values

Secondary Outcome Measures

PK characteristics: GNbAC1 serum concentrations [57 days]
GNbAC1 serum concentrations over time
immunogenicity in terms of antibodies against GNbAC1 (anti-drug antibodies) [57 days]
antibodies against GNbAC1 (anti-drug antibodies)
ratio of serum to CSF GNbAC1 concentration [29 days]
GNbAC1 cerebrospinal fluid concentration at Day 2 and Weeks 2 and 4 after administration

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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.

NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.