NCT05528315

SAD/MAD of ABX-002-1902 Investigating the Safety, Pharmacokinetics/Pharmacodynamics of in Healthy Subjects

A Phase 1 Double-Blind, Randomized, Placebo-Controlled, Single and Multiple Ascending Dose Study of the Safety, Pharmacokinetics, and Pharmacodynamics of ABX-002 in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Autobahn Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The study will evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single-ascending doses (SAD) and multiple ascending doses (MAD) of ABX-002 in healthy volunteers (HV)

Detailed description

The study will evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single-ascending doses (SAD) and multiple ascending doses (MAD) of ABX-002 in healthy volunteers (HV) to identify repeated dose levels that are safe and well-tolerated.

Conditions

• MDD

Interventions

Type	Name	Description
DRUG	ABX-002	ABX-002
DRUG	Placebo	Placebo

Timeline

• Start date: 2022-10-12
• Primary completion: 2023-06-26
• Completion: 2023-09-13
• First posted: 2022-09-06
• Last updated: 2023-09-15

Locations

1 site across 1 country: Australia