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

  • STATUS
    Recruiting
  • participants needed
    88
  • sponsor
    Enterprise Therapeutics Ltd
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Updated on 19 February 2024
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cystic fibrosis

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.

Details
Condition Healthy
Age 18years - 50years
Treatment ETD002 - single dose, Placebo - single dose, ETD002 - 7 day repeat dose, Placebo - 7 day repeat dose, ETD002 - 14 day repeat dose, Placebo - 14 day repeat dose
Clinical Study IdentifierNCT04488705
SponsorEnterprise Therapeutics Ltd
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

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
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