NCT04926701

A First in Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of Inhaled ETD001 in Healthy Subjects

A First in Human Randomised, Double Blind, Placebo-controlled, Two-part Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses (SAD and MAD) of Inhaled ETD001 in Healthy Male and Female Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: Enterprise Therapeutics Ltd · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This is a first in human study of ETD001 a new drug being developed for the treatment of cystic fibrosis. The study is a randomised, placebo-controlled, double-blind interventional study to assess the safety, tolerability and pharmacokinetics of single and multiple ascending doses of inhaled ETD001in healthy male and female subjects.

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
DRUG	ETD001 single dose	Single ascending doses of inhaled ETD001
DRUG	Placebo single dose	Single doses of inhaled placebo
DRUG	ETD001 multiple twice daily doses	Ascending doses of inhaled ETD001 administered twice daily
DRUG	Placebo multiple twice daily doses	Doses of inhaled placebo administered twice daily
DRUG	ETD001 multiple once daily doses	Doses of inhaled ETD001 administered once daily
DRUG	Placebo multiple once daily doses	Doses of inhaled placebo administered once daily

Timeline

• Start date: 2021-06-11
• Primary completion: 2022-03-22
• Completion: 2022-03-22
• First posted: 2021-06-15
• Last updated: 2022-03-24

Locations

1 site across 1 country: United Kingdom