Safety Study of GNbAC1 Monoclonal Antibody in Healthy Male Volunteers

Study Overview
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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.

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.

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

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: GNbAC1


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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 6 mg/kg GNbAC1<br>7 subjects randomized 5:2 active treatment:placebo | Drug: GNbAC1<br>* Single dose of IMP, IV infusion<br>|
| Active Comparator: 18 mg/kg GNbAC1<br>7 subjects randomized 5:2 active treatment:placebo | Drug: GNbAC1<br>* Single dose of IMP, IV infusion<br>|
| Active Comparator: 36 mg/kg GNbAC1<br>7 subjects randomized 5:2 active treatment:placebo | Drug: GNbAC1<br>* Single dose of IMP, IV infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety and tolerability of single ascending doses of GNbAC1 in healthy male subjects | AE, SAE, vital signs, ECG, clinical laboratory values | 57 days | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Temelimab, GNbAC1, Multiple Sclerosis, Multiple Sclerosis Associated Retrovirus (MSRV), MSRV-Envelope protein, Monoclonal antibody