Single Ascending Doses Study With GNbAC1 in Healthy Male Volunteers
- Registration Number
- NCT03574428
- Lead Sponsor
- GeNeuro Australia PTY Ltd
- Brief Summary
This is a phase I, double-blind, placebo controlled, parallel group, dose-escalating, randomised study designed to assess and compare the safety and tolerability, PK, and immunogenicity of GNbAC1 administered as a single dose at 4 different dose levels of 36, 60, 85 and 110 mg/kg.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 24
Inclusion Criteria
- Healthy male volunteers
- Negative urine drug screen
- Have signed the informed consent.
Main
Exclusion Criteria
- History of serious adverse reactions or hypersensitivity to any drug.
- Use of any prescription medication within 30 days prior to the administration of investigational product and/or non-prescription medication (including herbal and natural remedies, homeopathy, vitamins, and minerals) within 7 days prior to the administration of investigational product or anticipated use of any concomitant medication during the study. Permissible exceptions are paracetamol up to 4g/day ceasing a minimum of 12 hours prior to infusion and Ibuprofen up to 1.2g/day ceasing a minimum of 24 hours prior to infusion. Paracetamol and ibuprofen are allowed during the study, but only 24 hours after completion of the administration of investigational product.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Cohort 1 GNbAC1 GNbAC1 36 mg/kg single i.v. dose or GNbAC1 placebo Cohort 1 GNbAC1 Placebo GNbAC1 36 mg/kg single i.v. dose or GNbAC1 placebo Cohort 2 GNbAC1 GNbAC1 60 mg/kg single i.v. dose or GNbAC1 placebo Cohort 2 GNbAC1 Placebo GNbAC1 60 mg/kg single i.v. dose or GNbAC1 placebo Cohort 3 GNbAC1 GNbAC1 85 mg/kg single i.v. dose or GNbAC1 placebo Cohort 3 GNbAC1 Placebo GNbAC1 85 mg/kg single i.v. dose or GNbAC1 placebo Cohort 4 GNbAC1 Placebo GNbAC1 110 mg/kg single i.v. dose or GNbAC1 placebo Cohort 4 GNbAC1 GNbAC1 110 mg/kg single i.v. dose or GNbAC1 placebo
- Primary Outcome Measures
Name Time Method Safety and tolerability of single ascending doses of GNbAC1 (Serious Adverse Events, Adverse Events) 57 days Serious Adverse Events (SAE), Adverse Events (AE)
- Secondary Outcome Measures
Name Time Method Pharmacokinetic (PK): GNbAC1 serum concentrations over time 57 days GNbAC1 serum concentrations over time
Immunogenicity: Antibodies against GNbAC1 (ADA) 57 days Antibodies against GNbAC1 (ADA)
Trial Locations
- Locations (1)
Scientia Clinical Research Ltd
🇦🇺Sydney, New South Wales, Australia