Clinical trial 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
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Cystic fibrosis
Lead sponsor: Enterprise Therapeutics Ltd
Sponsor class: INDUSTRY
First posted: 2020-07-28
Enrollment: 80
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 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.


Eligibility criteria: 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

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 safety 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 ETD002
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: David Morris, MD
role: STUDY_DIRECTOR
References: