Overview
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.
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