A First in Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of Inhaled ETD002 in Healthy Subjects

Phase 1 Completed 80 enrolled Enterprise Therapeutics Ltd

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a first in human study of ETD002 a new drug being developed for the treatment of cystic fibrosis.The study is a randomised, double-blind, placebo-controlled, interventional study to assess the safety and tolerability of ascending single and repeat doses of inhaled ETD002 in healthy male and female subjects.

Timeline

Start: 2020-08-13
Primary completion: 2021-05-19
Completion: 2021-05-19

Publications

Miller P, Repplinger D, Zhu R, Chen Y, Lewin-Koh N, Morris D, Russell P, She G, Singh N, White R, Wilkes D, Chen H, Galanter J. Randomized, phase I studies to evaluate the safety, tolerability, and pharmacokinetics of an inhaled, TMEM16A potentiator, GDC-6988, in healthy subjects. Ther Adv Respir Dis. 2025 Jan-Dec;19:17534666251393346. doi: 10.1177/17534666251393346. Epub 2025 Nov 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ETD002	Unknown	1.5 mg	Inhaled
Subject	ETD002	Unknown	22.5 mg	Inhaled
Subject	ETD002	Unknown	45 mg	Inhaled
Subject	ETD002	Unknown	75 mg	Inhaled
Subject	ETD002	Unknown	150 mg	Inhaled
Background	Salbutamol	Unknown	—	—

Indications

No indication recorded.