A Randomised, Double-Blind, Placebo Controlled, Single Ascending Doses Study With GNbAC1 in Healthy Male Volunteers
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- GeNeuro Innovation SAS
- Enrollment
- 21
- Locations
- 1
- Primary Endpoint
- safety and tolerability of single ascending doses of GNbAC1 in healthy male subjects
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
6 mg/kg GNbAC1
7 subjects randomized 5:2 active treatment:placebo
Intervention: GNbAC1 (Drug)
18 mg/kg GNbAC1
7 subjects randomized 5:2 active treatment:placebo
Intervention: GNbAC1 (Drug)
36 mg/kg GNbAC1
7 subjects randomized 5:2 active treatment:placebo
Intervention: GNbAC1 (Drug)
Outcomes
Primary Outcomes
safety and tolerability of single ascending doses of GNbAC1 in healthy male subjects
Time Frame: 57 days
AE, SAE, vital signs, ECG, clinical laboratory values
Secondary Outcomes
- PK characteristics: GNbAC1 serum concentrations(57 days)
- immunogenicity in terms of antibodies against GNbAC1 (anti-drug antibodies)(57 days)
- ratio of serum to CSF GNbAC1 concentration(29 days)