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 Australia PTY Ltd
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Safety and tolerability of single ascending doses of GNbAC1 (Serious Adverse Events, Adverse Events)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- 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 volunteers
- •Negative urine drug screen
- •Have signed the informed consent.
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.
Arms & Interventions
Cohort 1
GNbAC1 36 mg/kg single i.v. dose or GNbAC1 placebo
Intervention: GNbAC1 Placebo (Other)
Cohort 1
GNbAC1 36 mg/kg single i.v. dose or GNbAC1 placebo
Intervention: GNbAC1 (Drug)
Cohort 2
GNbAC1 60 mg/kg single i.v. dose or GNbAC1 placebo
Intervention: GNbAC1 (Drug)
Cohort 2
GNbAC1 60 mg/kg single i.v. dose or GNbAC1 placebo
Intervention: GNbAC1 Placebo (Other)
Cohort 3
GNbAC1 85 mg/kg single i.v. dose or GNbAC1 placebo
Intervention: GNbAC1 (Drug)
Cohort 3
GNbAC1 85 mg/kg single i.v. dose or GNbAC1 placebo
Intervention: GNbAC1 Placebo (Other)
Cohort 4
GNbAC1 110 mg/kg single i.v. dose or GNbAC1 placebo
Intervention: GNbAC1 (Drug)
Cohort 4
GNbAC1 110 mg/kg single i.v. dose or GNbAC1 placebo
Intervention: GNbAC1 Placebo (Other)
Outcomes
Primary Outcomes
Safety and tolerability of single ascending doses of GNbAC1 (Serious Adverse Events, Adverse Events)
Time Frame: 57 days
Serious Adverse Events (SAE), Adverse Events (AE)
Secondary Outcomes
- Pharmacokinetic (PK): GNbAC1 serum concentrations over time(57 days)
- Immunogenicity: Antibodies against GNbAC1 (ADA)(57 days)