Safety Study of GNbAC1 Monoclonal Antibody in Healthy Male Volunteers

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

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: GNbAC1

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 Type: Interventional
• Enrollment (Anticipated): 21
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 14050
    • PAREXEL Early Phase Clinical Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: GeNeuro Innovation SAS
• Investigators: Principal Investigator: Georg Golor, MD, Parexel

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: May 21, 2015
• First Submitted That Met QC Criteria: May 22, 2015
• First Posted (Estimate): May 25, 2015

Study Record Updates

• Last Update Posted (Actual): October 20, 2020
• Last Update Submitted That Met QC Criteria: October 19, 2020
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: Multiple Sclerosis; Monoclonal antibody; GNbAC1; Temelimab; Multiple Sclerosis Associated Retrovirus (MSRV); MSRV-Envelope protein
• Other Study ID Numbers: GNC-001bis; 2014-005113-23 (EudraCT Number)