Safety Study of GNbAC1 Monoclonal Antibody in Healthy Male Volunteers
- Registration Number
- NCT02452996
- Lead Sponsor
- GeNeuro Innovation SAS
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 21
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description 18 mg/kg GNbAC1 GNbAC1 7 subjects randomized 5:2 active treatment:placebo 6 mg/kg GNbAC1 GNbAC1 7 subjects randomized 5:2 active treatment:placebo 36 mg/kg GNbAC1 GNbAC1 7 subjects randomized 5:2 active treatment:placebo
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
PK characteristics: GNbAC1 serum concentrations 57 days GNbAC1 serum concentrations over time
Trial Locations
- Locations (1)
PAREXEL Early Phase Clinical Unit
🇩🇪Berlin, Germany