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

Phase 1

Completed

• Conditions: Cystic Fibrosis
• Interventions: Drug: ETD001 multiple twice daily doses; Drug: ETD001 single dose; Drug: Placebo single dose; Drug: Placebo multiple twice daily doses; Drug: ETD001 multiple once daily doses; Drug: Placebo multiple once daily doses

• Registration Number: NCT04926701
• Lead Sponsor: Enterprise Therapeutics Ltd

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-06-10
• Study First Submitted QC: 2021-06-10
• Study Start: 2021-06-11
• Study First Posted: 2021-06-15
• Status Verified: 2022-03
• Primary Completion: 2022-03-22
• Study Completion: 2022-03-22
• Last Update Submitted: 2022-03-23
• Last Update Posted: 2022-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multiple ascending dose (7 days)	ETD001 multiple twice daily doses	Daily doses of ETD001/placebo for 7 consecutive days
Multiple ascending dose (7 days)	Placebo multiple once daily doses	Daily doses of ETD001/placebo for 7 consecutive days
Multiple ascending dose (7 days)	ETD001 multiple once daily doses	Daily doses of ETD001/placebo for 7 consecutive days
Multiple ascending dose (14 days)	ETD001 multiple twice daily doses	Daily doses of ETD001/placebo for 14 consecutive days
Single ascending dose	ETD001 single dose	Single dose of inhaled ETD001/placebo on one occasion
Single ascending dose	Placebo single dose	Single dose of inhaled ETD001/placebo on one occasion
Multiple ascending dose (7 days)	Placebo multiple twice daily doses	Daily doses of ETD001/placebo for 7 consecutive days
Multiple ascending dose (14 days)	Placebo multiple twice daily doses	Daily doses of ETD001/placebo for 14 consecutive days

Primary Outcome Measures

Name	Time	Method
Number of participants who discontinue due to an adverse event (AE)	Baseline to Week 8
Number of participants who meet the markedly abnormal criteria for 12-lead ECG assessment at least once post dose	Baseline to Week 8
Number of participants who meet the markedly abnormal criteria for laboratory assessments at least once post dose	Baseline to Week 8
Number of participants reporting one or more treatment emergent adverse event (TEAE)	Baseline to Week 8
Number of participants who meet the markedly abnormal criteria for vital signs assessments at least once post dose	Baseline to Week 8
Number of participants who meet the markedly abnormal criteria for spirometry assessments at least once post dose	Baseline to Week 8

Secondary Outcome Measures

Name	Time	Method
Plasma concentrations of ETD001	Day 1 pre-dose and at multiple time-points (up to 14 days) post final dose	Blood levels of ETD001 measured after dosing

Trial Locations

Locations (1)

Hammersmith Medicines Research; 🇬🇧 London, United Kingdom