Safety Issues
Conditions
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.
Sponsors
Etern Therapeutics Wuxi Limited
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
16 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
\- Subjects meeting any of the following
Exclusion criteria
will be excluded from this trial: 1. Fully understand the purpose, nature and methodology of the trial, as well as potential adverse reactions, and voluntarily sign the informed consent form. 2. Healthy male or female Chinese subjects aged between 18 and 60 years inclusive (age determined on the date of signing the informed consent form). 3. 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. 4. No skin rupture, lesions (including skin lesions caused by dermatoses), redness, rash, pigmentation, tattoos, excessive hair or abnormal warmth at the intended application site. 5. 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). 6. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the safety and tolerability of ETD-001 in healthy Chinese subjects. | Up to Day 21 | Number of participants with treatment-related adverse events as assessed by CTCAE v6.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the pharmacokinetic characteristics of ETD-001 gel in healthy Chinese subjects. | Up to Day 21 | Area Under Concentration-time \[ AUC\] of ETD-001cgel |
Countries
China
Outcome results
None listed