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

A First in Human Randomised, Double Blind, Placebo-controlled, Two-part Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses (SAD and MAD) of Inhaled ETD001 in Healthy Male and Female Subjects

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.

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

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