Single Ascending Doses Study With GNbAC1 in Healthy Male Volunteers

• Status: Completed
• Trial end date: 2018-11-02
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: GeNeuro Australia PTY Ltd

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.