Phase 1 Safety and Pharmacokinetics Study of ENC0653 Ointment Applied to Skin in Healthy Adults Aged 18 to 55

What This Trial Is About

Researchers are conducting a first-in-human, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and how the body processes ENC0653 ointment when applied to the skin of healthy adult volunteers aged 18 to 55 years. This phase 1 trial is designed to assess the effects of single and multiple topical doses of the ointment in a controlled setting. The study has two parts Part A involves a single ascending dose SAD where participants receive one application of the ointment or placebo, and Part B involves multiple ascending doses MAD with twice-daily applications for seven days followed by a single dose on the eighth day. Up to 56 participants will be enrolled in up to seven cohorts, with dosing adjusted based on safety and drug concentration data reviewed by a Safety Review Committee. Each cohort includes 8 subjects, 6 receiving ENC0653 ointment and 2 receiving placebo. Participants will be closely monitored from 28 days before dosing until shortly after the last dose for any treatment-emergent adverse events and serious adverse events. Blood samples will be collected to measure drug levels in plasma up to 72 hours post-dose. The study includes regular assessments to track safety, tolerability, and pharmacokinetics, with the total participation period varying by dose group. This trial will help understand the ointments effects and guide future studies.

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