In this clinical study, the safety and tolerability of GNbAC1 as a treatment for MS patients will be evaluated in healthy male volunteers.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
21
Single dose of IMP, IV infusion
PAREXEL Early Phase Clinical Unit
Berlin, Germany
safety and tolerability of single ascending doses of GNbAC1 in healthy male subjects
AE, SAE, vital signs, ECG, clinical laboratory values
Time frame: 57 days
PK characteristics: GNbAC1 serum concentrations
GNbAC1 serum concentrations over time
Time frame: 57 days
immunogenicity in terms of antibodies against GNbAC1 (anti-drug antibodies)
antibodies against GNbAC1 (anti-drug antibodies)
Time frame: 57 days
ratio of serum to CSF GNbAC1 concentration
GNbAC1 cerebrospinal fluid concentration at Day 2 and Weeks 2 and 4 after administration
Time frame: 29 days
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