NCT07347678

Phase 1a Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RN5681 in Healthy Volunteers

A Phase 1a, Randomized, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RN5681 in Healthy Volunteers

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Ikaria Bioscience Pty Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of single doses of RN5681 in Adult healthy subjects

Conditions

• High Cholesterol

Interventions

Type	Name	Description
DRUG	RN5681	Investigational Product
DRUG	Placebo control	0.9% normal saline SC injection

Timeline

• Start date: 2026-03-12
• Primary completion: 2027-02-01
• Completion: 2027-07-01
• First posted: 2026-01-16
• Last updated: 2026-04-03

Locations

2 sites across 1 country: Australia