Safety, Tolerability and Pharmacokinetics of ETD-001 Gel (NCT07674862) | Clinical Trial Compass
By InvitationPhase 1
Safety, Tolerability and Pharmacokinetics of ETD-001 Gel
China56 participantsStarted 2026-03-16
Plain-language 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.
Who can participate
Age range
16 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Exclusion criteria
. 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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To evaluate the safety and tolerability of ETD-001 in healthy Chinese subjects.
. 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.