Safety, Tolerability and Pharmacokinetics of ETD-001 Gel

NCT07674862 | Enrolling By Invitation Phase 1

• 1 other identifier: ETD-001-101-A
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• To evaluate the safety and tolerability of ETD-001 in healthy Chinese subjects.

  Number of participants with treatment-related adverse events as assessed by CTCAE v6.0

  Up to Day 21

Secondary Outcomes (1)

• To evaluate the pharmacokinetic characteristics of ETD-001 gel in healthy Chinese subjects.

  Up to Day 21

Study Arms (2)

ETD-001 gel

EXPERIMENTAL

QD，topical administration

Drug: Dose 1; Drug: dose 2; Drug: dose 3

PLACEBO

PLACEBO COMPARATOR

QD，topical administration

Drug: Dose 1; Drug: dose 2; Drug: dose 3

Interventions

dose 2 DRUG

middle dose

ETD-001 gel; PLACEBO

Dose 1 DRUG

low dose

ETD-001 gel; PLACEBO

dose 3 DRUG

high dose

ETD-001 gel; PLACEBO

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may not qualify if:

• Fully understand the purpose, nature and methodology of the trial, as well as potential adverse reactions, and voluntarily sign the informed consent form.
• Healthy male or female Chinese subjects aged between 18 and 60 years inclusive (age determined on the date of signing the informed consent form).
• Body Mass Index (BMI) ranging from 19 to 26 kg/m² inclusive; male subjects shall weigh no less than 50 kg, and female subjects no less than 45 kg.
• No skin rupture, lesions (including skin lesions caused by dermatoses), redness, rash, pigmentation, tattoos, excessive hair or abnormal warmth at the intended application site.
• Subjects are deemed to be in good general health by the investigator based on medical history, physical examination, vital signs, 12-lead electrocardiogram, laboratory tests (blood routine, urine routine, blood biochemistry) and viral serology results (all findings are normal or abnormalities are clinically insignificant).
• Female subjects must be non-pregnant and non-lactating. All subjects, regardless of gender, must agree to use medically approved effective contraception from the screening period until 6 months after the last dose. They shall not donate sperm or ova during the study period and within 6 months after the last dose.
• Subjects who are allergic to the investigational drug or any of its excipients; those with allergic diathesis (e.g., allergy to two or more types of drugs, foods or pollen); or those with severe systemic allergic diseases (e.g., severe asthma, allergic rhinitis, etc.).
• Subjects with clinically significant abnormal medical conditions or factors, including but not limited to metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, urological, endocrine, neurological and psychiatric diseases, or other conditions deemed inappropriate for participation in this study by the investigator.
• Subjects who have taken or are expected to take any prescription drugs, over-the-counter medications, vitamin products, health supplements or traditional 4.Chinese medicinal preparations within 14 days prior to the first dose, or within 5 half-lives of the study drug (whichever is longer); or those who have consumed foods or beverages that may induce or inhibit hepatic metabolic enzymes (e.g., grapefruit) within 7 days before dosing.
• Subjects with abnormal liver or renal function:
• Total Bilirubin (TBIL) \> 1.5 × ULN;
• AST or ALT ≥ 1.5 × ULN;
• Blood Urea Nitrogen (BUN) and Creatinine (CRE) \> 1.5 × ULN. 5.Subjects with confirmed positive test results for hepatitis B, hepatitis C, Human Immunodeficiency Virus (HIV) or syphilis at screening.
• Subjects with a history of drug abuse within the past five years, those who have used illicit drugs within 3 months prior to screening, or those with a positive drug abuse screening result at baseline.
• Subjects consuming more than 14 units of alcohol per week within 3 months prior to screening (1 alcohol unit = 360 mL beer, or 45 mL spirits with 40% alcohol content, or 150 mL wine); those who have consumed alcoholic products within 48 hours before receiving the investigational drug; or those with a positive breath alcohol test at baseline.

Sponsors & Collaborators

• Etern Therapeutics Wuxi Limited: lead

Study Sites (1)

Hangzhou

Hangzhou, Zhejiang, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2026
• First Posted: June 30, 2026
• Study Start: March 16, 2026
• Primary Completion: July 1, 2026
• Study Completion: July 1, 2026
• Last Updated: June 30, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)