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RECRUITING
NCT07684196
PHASE1

A First-in-Human SAD/MAD Study to Evaluate Safety, Tolerability and PK of ENC0653 Ointment in Healthy Adult Subjects

Sponsor: EnnovaBio

View on ClinicalTrials.gov

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

DRUG

Low Dose, 10%BSA

Topical dermal administration

DRUG

Low Dose, 20%BSA

Topical dermal administration

DRUG

Middle Dose, 20%BSA

Topical dermal administration

DRUG

High Dose, 20%BSA

Topical dermal administration

DRUG

Low Dose, 20%BSA

Topical dermal administration

DRUG

Middle Dose, 20%BSA

Topical dermal administration

DRUG

High Dose, 20%BSA

Topical dermal administration

DRUG

Placebo

Topical dermal administration

Locations (1)

Shanghai Xuhui Central Hospital

Shanghai, Xuhui District, China