Healthy Volunteers
Conditions
Keywords
GNbAC1, Multiple Sclerosis, Multiple Sclerosis Associated Retrovirus (MSRV), MSRV-Envelope protein, Monoclonal antibody, Temelimab
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.
Interventions
DRUGGNbAC1
Single dose of IMP, IV infusion
Sponsors
GeNeuro Innovation SAS
Study design
Allocation
RANDOMIZED
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| safety and tolerability of single ascending doses of GNbAC1 in healthy male subjects | 57 days | AE, SAE, vital signs, ECG, clinical laboratory values |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PK characteristics: GNbAC1 serum concentrations | 57 days | GNbAC1 serum concentrations over time |
| 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 |
Countries
Germany
Outcome results
None listed