Study to Evaluate the Safety of ATR-04

Summary

This is a multicenter, randomized, double-blind, placebo-controlled phase 1b/2a study designed to evaluate the safety of an investigational product called ATR-04, to reduce the severity of epidermal growth factor receptor inhibitor (EGFRI) associated papulopustular rash on the face. This study will be performed at 10-12 clinical sites, with potentially a virtual component. Approximately 60 eligible subjects will participate. A subject's participation in the study will be up to a maximum of 86 days (up to 28 days for Screening, 28 days of BID treatment, and a 30 day no treatment follow-up period). The primary objective of this study is to evaluate the safety and tolerability of ATR-04 compared to placebo.

Timeline

Start

2024-01

Primary completion

2026-01

Completion

2026-01

Outcome

Outcome not reported

Stopped (Business): “Business reasons.”

Drugs

Indications