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A First in Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of Inhaled ETD001 in Healthy Subjects

NCT04926701 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2022-03-24

No results posted yet for this study

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.

Conditions

Interventions

DRUG

ETD001 multiple once daily doses

Doses of inhaled ETD001 administered once daily

DRUG

Placebo multiple once daily doses

Doses of inhaled placebo administered once daily

DRUG

ETD001 single dose

Single ascending doses of inhaled ETD001

DRUG

Placebo single dose

Single doses of inhaled placebo

DRUG

ETD001 multiple twice daily doses

Ascending doses of inhaled ETD001 administered twice daily

DRUG

Placebo multiple twice daily doses

Doses of inhaled placebo administered twice daily

Sponsors & Collaborators

  • Enterprise Therapeutics Ltd

    lead INDUSTRY

Principal Investigators

  • Niyati Prasad, 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
2021-06-11
Primary Completion
2022-03-22
Completion
2022-03-22

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT04926701 on ClinicalTrials.gov