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NCT Number: NCT04488705

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

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.

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Key information

Conditions

Healthy Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cystic Fibrosis 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 & 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

Treatment and study plan

ETD002 - single dose

Drug

Single ascending doses of ETD002

Placebo - single dose

Drug

Single doses of placebo

ETD002 - 7 day repeat dose

Drug

Twice daily doses of ETD002 for 7 days

Placebo - 7 day repeat dose

Drug

Twice daily doses of Placebo for 7 days

ETD002 - 14 day repeat dose

Drug

Twice daily doses of ETD002 for 14 days

Placebo - 14 day repeat dose

Drug

Twice daily doses of Placebo for 14 days

Salbutamol

Drug

Twice daily doses of salbutamol for 3 days (Days 5, 6 & 7)

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 safety 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 ETD002

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

    Blood levels of ETD002 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, Three-part Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses (SAD & MAD) of Inhaled ETD002 in Healthy Male and Female Subjects

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 28, 2020
Registry last updated
May 21, 2021

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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