Single Ascending Doses Study With GNbAC1 in Healthy Male Volunteers

Study Overview
=================
Brief Summary
-----------------
This is a phase I, double-blind, placebo controlled, parallel group, dose-escalating, randomised study designed to assess and compare the safety and tolerability, PK, and immunogenicity of GNbAC1 administered as a single dose at 4 different dose levels of 36, 60, 85 and 110 mg/kg.

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

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Drug: GNbAC1
* Other: GNbAC1 Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Main Inclusion Criteria: Healthy male volunteers Negative urine drug screen Have signed the informed consent. Main Exclusion Criteria: History of serious adverse reactions or hypersensitivity to any drug. Use of any prescription medication within 30 days prior to the administration of investigational product and/or non-prescription medication (including herbal and natural remedies, homeopathy, vitamins, and minerals) within 7 days prior to the administration of investigational product or anticipated use of any concomitant medication during the study. Permissible exceptions are paracetamol up to 4g/day ceasing a minimum of 12 hours prior to infusion and Ibuprofen up to 1.2g/day ceasing a minimum of 24 hours prior to infusion. Paracetamol and ibuprofen are allowed during the study, but only 24 hours after completion of the administration of investigational product.

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

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cohort 1<br>GNbAC1 36 mg/kg single i.v. dose or GNbAC1 placebo | Drug: GNbAC1<br>* Monoclonal Antibody infused i.v.<br>Other: GNbAC1 Placebo<br>* Equivalent to GNbAC1 Buffer<br>|
| Active Comparator: Cohort 2<br>GNbAC1 60 mg/kg single i.v. dose or GNbAC1 placebo | Drug: GNbAC1<br>* Monoclonal Antibody infused i.v.<br>Other: GNbAC1 Placebo<br>* Equivalent to GNbAC1 Buffer<br>|
| Active Comparator: Cohort 3<br>GNbAC1 85 mg/kg single i.v. dose or GNbAC1 placebo | Drug: GNbAC1<br>* Monoclonal Antibody infused i.v.<br>Other: GNbAC1 Placebo<br>* Equivalent to GNbAC1 Buffer<br>|
| Active Comparator: Cohort 4<br>GNbAC1 110 mg/kg single i.v. dose or GNbAC1 placebo | Drug: GNbAC1<br>* Monoclonal Antibody infused i.v.<br>Other: GNbAC1 Placebo<br>* Equivalent to GNbAC1 Buffer<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of single ascending doses of GNbAC1 (Serious Adverse Events, Adverse Events) | Serious Adverse Events (SAE), Adverse Events (AE) | 57 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic (PK): GNbAC1 serum concentrations over time | GNbAC1 serum concentrations over time | 57 days | 
| Immunogenicity: Antibodies against GNbAC1 (ADA) | Antibodies against GNbAC1 (ADA) | 57 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Temelimab