NCT04488705

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

A First in Human, Randomised, Double Blind, Placebo-controlled, Three-part Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses (SAD & MAD) of Inhaled ETD002 in Healthy Male and Female Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (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 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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	ETD002 - single dose	Single ascending doses of ETD002
DRUG	Placebo - single dose	Single doses of placebo
DRUG	ETD002 - 7 day repeat dose	Twice daily doses of ETD002 for 7 days
DRUG	Placebo - 7 day repeat dose	Twice daily doses of Placebo for 7 days
DRUG	ETD002 - 14 day repeat dose	Twice daily doses of ETD002 for 14 days
DRUG	Placebo - 14 day repeat dose	Twice daily doses of Placebo for 14 days
DRUG	Salbutamol	Twice daily doses of salbutamol for 3 days (Days 5, 6 \& 7)

Timeline

• Start date: 2020-08-13
• Primary completion: 2021-05-19
• Completion: 2021-05-19
• First posted: 2020-07-28
• Last updated: 2021-05-21

Locations

1 site across 1 country: United Kingdom