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

NCT04488705 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2021-05-21

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DRUG

ETD002 - single dose

Single ascending doses of ETD002

DRUG

Placebo - single dose

Single doses of placebo

DRUG

ETD002 - 7 day repeat dose

Twice daily doses of ETD002 for 7 days

DRUG

Placebo - 7 day repeat dose

Twice daily doses of Placebo for 7 days

DRUG

ETD002 - 14 day repeat dose

Twice daily doses of ETD002 for 14 days

DRUG

Placebo - 14 day repeat dose

Twice daily doses of Placebo for 14 days

DRUG

Salbutamol

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

Sponsors & Collaborators

  • Enterprise Therapeutics Ltd

    lead INDUSTRY

Principal Investigators

  • David Morris, MD · Enterprise Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-08-13
Primary Completion
2021-05-19
Completion
2021-05-19

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04488705 on ClinicalTrials.gov