Clinical Trial

Safety, Tolerability and Pharmacokinetics of ETD-001 Gel

Study acronym: ETD-001 gel
Enrolling by Invitation Phase 1
View on ClinicalTrials.gov →
Record status
This record was last updated June 30, 2026 (before its estimated July 2026 completion). Its status may not reflect the trial's current state.
Summary
This is a single-center, randomized, double-blind, placebo-controlled Phase I clinical study, which comprises two parts: Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) in healthy subjects.Three dose groups are pre-scheduled for the SAD part. After the safety and tolerability of subjects in the second SAD dose group are confirmed, the MAD part will be initiated upon evaluation by the Safety Review Committee (SRC). Four dose groups are tentatively planned for the MAD part.Each dose group will enroll 8 subjects, who will be randomized at a 6:2 ratio to receive either ETD-001 gel or placebo.
Trial Details
NCT Number NCT07674862
Lead Sponsor Etern Therapeutics Wuxi Limited
Conditions Safety Issues
Enrollment 56 participants
Start Date 2026-03-16
Primary Completion 2026-07 (estimated)
Study Completion 2026-07 (estimated)
Updated on ClinicalTrials.gov 2026-06-30