Safety Study of GNbAC1 Monoclonal Antibody in Healthy Male Volunteers

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02452996
• Other study ID #: GNC-001bis
• Secondary ID: 2014-005113-23
• Status: Completed
• Phase: Phase 1
• Start date: April 2015
• Est. completion date: August 2015

Study information

• Verified date: August 2015
• Source: GeNeuro SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• GNbAC1
Single dose of IMP, IV infusion

Locations

Country	Name	City	State
Germany	PAREXEL Early Phase Clinical Unit	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
GeNeuro Innovation SAS

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	safety and tolerability of single ascending doses of GNbAC1 in healthy male subjects	AE, SAE, vital signs, ECG, clinical laboratory values	57 days
Secondary	PK characteristics: GNbAC1 serum concentrations	GNbAC1 serum concentrations over time	57 days
Secondary	immunogenicity in terms of antibodies against GNbAC1 (anti-drug antibodies)	antibodies against GNbAC1 (anti-drug antibodies)	57 days
Secondary	ratio of serum to CSF GNbAC1 concentration	GNbAC1 cerebrospinal fluid concentration at Day 2 and Weeks 2 and 4 after administration	29 days