Status:
COMPLETED
A First in Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of Inhaled ETD002 in Healthy Subjects
Lead Sponsor:
Enterprise Therapeutics Ltd
Conditions:
Healthy
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 19 2021
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04488705
Start Date
August 13 2020
End Date
May 19 2021
Last Update
May 21 2021
Active Locations (1)
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1
Hammersmith Medicines Research
London, United Kingdom, NW10 7EW