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NCT Number: NCT04926701

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

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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hammersmith Medicines Research

London, NW10 7EW, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ETD001 single dose

Drug

Single ascending doses of inhaled ETD001

Placebo single dose

Drug

Single doses of inhaled placebo

ETD001 multiple twice daily doses

Drug

Ascending doses of inhaled ETD001 administered twice daily

Placebo multiple twice daily doses

Drug

Doses of inhaled placebo administered twice daily

ETD001 multiple once daily doses

Drug

Doses of inhaled ETD001 administered once daily

Placebo multiple once daily doses

Drug

Doses of inhaled placebo administered once daily

Primary outcomes

  1. Number of participants reporting one or more treatment emergent adverse event (TEAE)

    Time frame: Baseline to Week 8

  2. Number of participants who discontinue due to an adverse event (AE)

    Time frame: Baseline to Week 8

  3. Number of participants who meet the markedly abnormal criteria for 12-lead ECG assessment at least once post dose

    Time frame: Baseline to Week 8

  4. Number of participants who meet the markedly abnormal criteria for vital signs assessments at least once post dose

    Time frame: Baseline to Week 8

  5. Number of participants who meet the markedly abnormal criteria for laboratory assessments at least once post dose

    Time frame: Baseline to Week 8

  6. Number of participants who meet the markedly abnormal criteria for spirometry assessments at least once post dose

    Time frame: Baseline to Week 8

Secondary outcomes

  1. Plasma concentrations of ETD001

    Time frame: Day 1 pre-dose and at multiple time-points (up to 14 days) post final dose

    Blood levels of ETD001 measured after dosing

Sponsors and collaborators

Lead sponsor

Enterprise Therapeutics Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 15, 2021
Registry last updated
Mar 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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