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A First-in-Human SAD/MAD Study to Evaluate Safety, Tolerability and PK of ENC0653 Ointment in Healthy Adult Subjects
Sponsor: EnnovaBio
Summary
This is a FIH, randomized, double-blind, single-center, placebo-controlled, dose -escalation clinical study to evaluate the safety, tolerability and pharmacokinetics of ENC0653 ointment following single and multiple topical dermal administration in healthy adult subjects. Up to 56 subjects will be enrolled at a single site in up to 4 cohorts in Part A (SAD study), and up to 3 cohorts in Part B (MAD study). Part A is for the single dose use of IP, while Part B is twice-daily use for 7 consecutive days and once daily use on Day 8. Each cohort will include 8 subjects (6 receiving ENC0653 ointment and 2 receiving placebo ointment). Dosing will be escalated on a review of safety, tolerability, and available PK data by a Safety Review Committee (SRC).
Official title: A Phase 1 Randomized, Double-Blind, Single-Center, Placebo-Controlled Single Ascending Dose and Multiple Ascending Dose (SAD/MAD) Study by Topical Dermal Administration to Evaluate the Safety, Tolerability, and Pharmacokinetics of ENC0653 Ointment in Healthy Adult Subjects
Key Details
Gender
All
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
56
Start Date
2026-06-17
Completion Date
2026-12-30
Last Updated
2026-07-06
Healthy Volunteers
Yes
Conditions
Interventions
Low Dose, 10%BSA
Topical dermal administration
Low Dose, 20%BSA
Topical dermal administration
Middle Dose, 20%BSA
Topical dermal administration
High Dose, 20%BSA
Topical dermal administration
Low Dose, 20%BSA
Topical dermal administration
Middle Dose, 20%BSA
Topical dermal administration
High Dose, 20%BSA
Topical dermal administration
Placebo
Topical dermal administration
Locations (1)
Shanghai Xuhui Central Hospital
Shanghai, Xuhui District, China