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

NCT07684196 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2026-07-06

No results posted yet for this study

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).

Conditions

  • Healthy

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

Sponsors & Collaborators

  • EnnovaBio

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-06-17
Primary Completion
2026-10-01
Completion
2026-12-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07684196 on ClinicalTrials.gov