NCT07514780

To Evaluate the Safety, Pharmacokinetic and Pharmacodynamics of JW0061 in Healthy Volunteers

A Phase 1, Randomized, Double-blind, Placebo-controlled, Dose Escalation Clinical Trial to Evaluate the Safety, Pharmacokinetic and Pharmadynamics of JW0061 Following Topical Application in Korean and Caucasians Healthy Adults

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 104 (estimated)
• Sponsor: JW Pharmaceutical · Industry
• Sex: All
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This clinical study is a phase 1, randomized, double-blind, placebo-controlled, dose escalation clinical trial to evaluate the safety, pharmacokinetic and pharmacodynamics of JW0061 following topical application in Korean and Caucasians healthy adults.

Detailed description

The study is divided into two parts: * Part 1 (Korean Healthy Adults): Consists of 5 cohorts each for Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) stages. * Part 2 (Caucasian Healthy Adults): Consists of 2 cohorts each for SAD and MAD stages to evaluate the drug in a different ethnic group.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	JW0061 SAD	Single ascending doses
DRUG	JW0061 MAD	Multiple ascending doses
DRUG	Placebo	Matching placebo for JW0061

Timeline

• Start date: 2026-03-31
• Primary completion: 2026-12-31
• Completion: 2027-04-30
• First posted: 2026-04-07
• Last updated: 2026-04-07

Locations

1 site across 1 country: South Korea