NCT03173625

A Study Conducted in Healthy Male Subjects to Investigate the Safety and Tolerability of AC-76, Its Fate in the Body, and Its Effect on the Body

Single-center, Double-blind, Placebo-controlled, Randomized, Single-ascending Dose Study to Investigate the Tolerability, Safety, Pharmacokinetics, and Pharmacodynamics of AC-076 in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Viatris Innovation GmbH · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The main objective of the study is to investigate the safety and tolerability of single ascending doses of AC-076 administered as subcutaneous injection

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	AC-076 for s.c. administration	Lyophilized AC-076A to be reconstituted with 1 mL of water for injection
DRUG	Placebo	Sterile 0.9% w/v sodium chloride solution

Timeline

• Start date: 2016-11-29
• Primary completion: 2017-04-15
• Completion: 2017-04-15
• First posted: 2017-06-02
• Last updated: 2025-07-02

Locations

1 site across 1 country: United States