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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04488705
• Other study ID #: ET-TMEM-01
• Secondary ID: 2020-001080-92
• Status: Completed
• Phase: Phase 1
• Start date: August 13, 2020
• Est. completion date: May 19, 2021

Study information

• Verified date: May 2021
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 19, 2021
• Est. primary completion date: May 19, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• ETD002 - single dose
Single ascending doses of ETD002
• Placebo - single dose
Single doses of placebo
• ETD002 - 7 day repeat dose
Twice daily doses of ETD002 for 7 days
• Placebo - 7 day repeat dose
Twice daily doses of Placebo for 7 days
• ETD002 - 14 day repeat dose
Twice daily doses of ETD002 for 14 days
• Placebo - 14 day repeat dose
Twice daily doses of Placebo for 14 days
• Salbutamol
Twice daily doses of salbutamol for 3 days (Days 5, 6 & 7)

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