MedTrace Logo

Safety, Tolerability and Pharmacokinetics of ETD-001 Gel

NCT07674862 · Status: ENROLLING_BY_INVITATION · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2026-06-30

No results posted yet for this study

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.

Conditions

  • Safety Issues

Interventions

DRUG

Dose 1

low dose

DRUG

dose 2

middle dose

DRUG

dose 3

high dose

Sponsors & Collaborators

  • Etern Therapeutics Wuxi Limited

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
16 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-03-16
Primary Completion
2026-07-31
Completion
2026-07-31

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07674862 on ClinicalTrials.gov