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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04488705

Enrollment

Registered

2020-07-28

Start date

2020-08-13

Completion date

2021-05-19

Last updated

2021-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Cystic fibrosis

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.

Interventions

DRUGETD002 - single dose

Single ascending doses of ETD002

DRUGPlacebo - single dose

Single doses of placebo

DRUGETD002 - 7 day repeat dose

Twice daily doses of ETD002 for 7 days

DRUGPlacebo - 7 day repeat dose

Twice daily doses of Placebo for 7 days

DRUGETD002 - 14 day repeat dose

Twice daily doses of ETD002 for 14 days

DRUGPlacebo - 14 day repeat dose

Twice daily doses of Placebo for 14 days

DRUGSalbutamol

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Number of participants who meet the markedly abnormal criteria for 12-lead ECG assessment at least once post dose	Baseline to Week 8
Number of participants reporting one or more treatment emergent adverse event (TEAE)	Baseline to Week 8
Number of participants who discontinue due to an adverse event (AE)	Baseline to Week 8
Number of participants who meet the markedly abnormal criteria for spirometry assessments at least once post dose	Baseline to Week 8
Number of participants who meet the markedly abnormal criteria for vital signs assessments at least once post dose	Baseline to Week 8
Number of participants who meet the markedly abnormal criteria for safety laboratory assessments at least once post dose	Baseline to Week 8

Secondary

Measure	Time frame	Description
Plasma concentrations of ETD002	Day 1 pre-dose and at multiple time points (up to 14 days) post final dose	Blood levels of ETD002 measured after dosing

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026