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

Cystic Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04926701
• Other study ID #: ET-ENAC-01
• Status: Completed
• Phase: Phase 1
• Start date: June 11, 2021
• Est. completion date: March 22, 2022

Study information

• Verified date: March 2022
• Source: Enterprise Therapeutics Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: March 22, 2022
• Est. primary completion date: March 22, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Males and females using suitable methods of contraception, or females of non-childbearing potential

• Consent to study participation

• Body weight = 50 kg and body mass index 19 - 30 kg/m2

• Vital sign assessments within the normal ranges

• Healthy as determined following physical and laboratory examinations at screening visit

• Spirometry readings (FEV1 and FVC) to be = 80% of predicted value

Exclusion Criteria:

• Acute or chronic illness detected at the screening visit

• Respiratory tract infection within 4 weeks of the screening visit

• Use of prescribed or OTC medication within 14 days of the screening visit

• History of regular alcohol use over the recommended limits within 6 months of screening, or history/evidence of alcohol or drug abuse

• Smoker or use of tobacco products within 6 months of screening

• Abnormal blood or urine laboratory test results at screening

• Recent participation (within 3 months) in another clinical trial

• Current, or history of, allergy that may be contraindicated

Related Conditions & MeSH terms

• Cystic Fibrosis

Intervention

Drug:
• ETD001 single dose
Single ascending doses of inhaled ETD001
• Placebo single dose
Single doses of inhaled placebo
• ETD001 multiple twice daily doses
Ascending doses of inhaled ETD001 administered twice daily
• Placebo multiple twice daily doses
Doses of inhaled placebo administered twice daily
• ETD001 multiple once daily doses
Doses of inhaled ETD001 administered once daily
• Placebo multiple once daily doses
Doses of inhaled placebo administered once daily

Locations

Country	Name	City	State
United Kingdom	Hammersmith Medicines Research	London

Sponsors (1)

Lead Sponsor	Collaborator
Enterprise Therapeutics Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants reporting one or more treatment emergent adverse event (TEAE)		Baseline to Week 8
Primary	Number of participants who discontinue due to an adverse event (AE)		Baseline to Week 8
Primary	Number of participants who meet the markedly abnormal criteria for 12-lead ECG assessment at least once post dose		Baseline to Week 8
Primary	Number of participants who meet the markedly abnormal criteria for vital signs assessments at least once post dose		Baseline to Week 8
Primary	Number of participants who meet the markedly abnormal criteria for laboratory assessments at least once post dose		Baseline to Week 8
Primary	Number of participants who meet the markedly abnormal criteria for spirometry assessments at least once post dose		Baseline to Week 8
Secondary	Plasma concentrations of ETD001	Blood levels of ETD001 measured after dosing	Day 1 pre-dose and at multiple time-points (up to 14 days) post final dose