Single Ascending Doses Study With GNbAC1 in Healthy Male Volunteers
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Cohort 1 GNbAC1 36 mg/kg single i.v. dose or GNbAC1 placebo |
Drug: GNbAC1
Monoclonal Antibody infused i.v.
Other: GNbAC1 Placebo
Equivalent to GNbAC1 Buffer
|
| Active Comparator: Cohort 2 GNbAC1 60 mg/kg single i.v. dose or GNbAC1 placebo |
Drug: GNbAC1
Monoclonal Antibody infused i.v.
Other: GNbAC1 Placebo
Equivalent to GNbAC1 Buffer
|
| Active Comparator: Cohort 3 GNbAC1 85 mg/kg single i.v. dose or GNbAC1 placebo |
Drug: GNbAC1
Monoclonal Antibody infused i.v.
Other: GNbAC1 Placebo
Equivalent to GNbAC1 Buffer
|
| Active Comparator: Cohort 4 GNbAC1 110 mg/kg single i.v. dose or GNbAC1 placebo |
Drug: GNbAC1
Monoclonal Antibody infused i.v.
Other: GNbAC1 Placebo
Equivalent to GNbAC1 Buffer
|
Outcome Measures
Primary Outcome Measures
- 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
- 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)
Eligibility Criteria
Criteria
Main 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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Scientia Clinical Research Ltd | Sydney | New South Wales | Australia | 2031 |
Sponsors and Collaborators
- GeNeuro Australia PTY Ltd
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GNC-006