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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ETD-001 gel | Experimental | QD,topical administration |
|
| PLACEBO | Placebo Comparator | QD,topical administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dose 1 | Drug | low dose |
| |
| dose 2 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the pharmacokinetic characteristics of ETD-001 gel in healthy Chinese subjects. | Area Under Concentration-time [ AUC] of ETD-001cgel | Up to Day 21 |
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Inclusion Criteria:
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Subjects meeting any of the following exclusion criteria will be excluded from this trial:
Exclusion Criteria:
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.
6.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.
7.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.
8.Subjects smoking more than 5 cigarettes per day or habitually using nicotine-containing products within 3 months prior to screening.
9.Subjects who have ingested any foods or beverages containing caffeine or xanthine or their metabolites (e.g., coffee, tea, chocolate) within 48 hours prior to the first dose.
10.Subjects who have received blood or blood products, or donated/lost more than 400 mL of blood within 3 months prior to the first dose; or those who plan to donate blood during the trial and within 3 months after trial completion.
11.Subjects who have participated in another clinical trial and taken other investigational products within 30 days prior to the first dose, or within 5 half-lives of the study drug (whichever is longer).
12.Subjects who have suffered from clinically significant severe illnesses or undergone major surgery within 28 days prior to the first dose, or who are expected to receive major surgery during the trial.
13.Subjects with difficult venous access or a history of needle phobia or hemophobia.
14.Female subjects with a positive pregnancy test at screening or baseline, who are breastfeeding or planning to become pregnant.
15.Subjects with a history of chronic skin diseases (e.g., eczema, psoriasis, etc.).
16.Any other conditions that, in the investigator's judgment, may prevent the subject from giving informed consent or complying with the trial protocol, or may compromise trial results or the subject's personal safety if the subject participates in the trial.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hangzhou | Hangzhou | Zhejiang | China |
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| Drug |
middle dose |
|
| dose 3 | Drug | high dose |
|