Clinical trial 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
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cystic Fibrosis
Lead sponsor: Enterprise Therapeutics Ltd
Sponsor class: INDUSTRY
First posted: 2021-06-15
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of participants reporting one or more treatment emergent adverse event (TEAE)
timeFrame: Baseline to Week 8
measure: Number of participants who discontinue due to an adverse event (AE)
timeFrame: Baseline to Week 8
measure: Number of participants who meet the markedly abnormal criteria for 12-lead ECG assessment at least once post dose
timeFrame: Baseline to Week 8
measure: Number of participants who meet the markedly abnormal criteria for vital signs assessments at least once post dose
timeFrame: Baseline to Week 8
measure: Number of participants who meet the markedly abnormal criteria for laboratory assessments at least once post dose
timeFrame: Baseline to Week 8
measure: Number of participants who meet the markedly abnormal criteria for spirometry assessments at least once post dose
timeFrame: Baseline to Week 8
Secondary outcomes:
measure: Plasma concentrations of ETD001
timeFrame: Day 1 pre-dose and at multiple time-points (up to 14 days) post final dose
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Hammersmith Medicines Research
Study officials:
affiliation: Enterprise Therapeutics
name: Niyati Prasad, MD
role: STUDY_DIRECTOR
References: