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

• Conditions: Healthy
• Interventions: Drug: ETD002 - 14 day repeat dose; Drug: ETD002 - single dose; Drug: ETD002 - 7 day repeat dose; Drug: Placebo - single dose; Drug: Placebo - 14 day repeat dose; Drug: Placebo - 7 day repeat dose; Drug: Salbutamol

• Registration Number: NCT04488705
• Lead Sponsor: Enterprise Therapeutics Ltd

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-23
• Study First Submitted QC: 2020-07-23
• Study First Posted: 2020-07-28
• Study Start: 2020-08-13
• Status Verified: 2021-05
• Primary Completion: 2021-05-19
• Study Completion: 2021-05-19
• Last Update Submitted: 2021-05-20
• Last Update Posted: 2021-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Males & females using suitable methods of contraception or females of non-childbearing potential
• Consent to study participation
• Body weight ≥ 50 kg and body mass index within the range 19 - 30 kg/m2
• Vital signs assessments within normal ranges
• Healthy as determined following physical examination at screening visit
• Spirometry readings (FEV1 and FVC) to be ≥ 80% of predicted value

Exclusion Criteria

• Acute or chronic illness detected at screening visit
• Respiratory tract infection within 4 weeks of the screening visit
• Use of prescription or OTC medication within 14 days of the screening visit
• History of regular alcohol consumption over recommended limits within 6 months of the study, or history/evidence of alcohol or drug abuse
• Smoking or use of tobacco products within 6 months of screening
• Abnormal blood/urine laboratory screening test results
• Current, or history of, allergy that may be contraindicated

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Repeat dose - 14 days	ETD002 - 14 day repeat dose	-
Single ascending dose	ETD002 - single dose	-
Single ascending dose	Placebo - single dose	-
Repeat dose - 7 days	ETD002 - 7 day repeat dose	-
Repeat dose - 14 days	Placebo - 14 day repeat dose	-
Repeat dose - 7 days with SABA	ETD002 - 7 day repeat dose	-
Repeat dose - 7 days	Placebo - 7 day repeat dose	-
Repeat dose - 7 days with SABA	Placebo - 7 day repeat dose	-
Repeat dose - 7 days with SABA	Salbutamol	-

Primary Outcome Measures

Name	Time	Method
Number of participants reporting one or more treatment emergent adverse event (TEAE)	Baseline to Week 8
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 spirometry assessments at least once post dose	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 safety laboratory assessments at least once post dose	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

Secondary Outcome Measures

Name	Time	Method
Plasma concentrations of ETD002	Day 1 pre-dose and at multiple time points (up to 14 days) post final dose	Blood levels of ETD002 measured after dosing

Trial Locations

Locations (1)

Hammersmith Medicines Research; 🇬🇧 London, United Kingdom