Ignite Creation Date:
2024-07-17 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06478706
Status:
RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-06-18
Brief Title:
A Two-Part Study to Evaluate the Efficacy Safety Tolerability and Pharmacokinetics of Repeat Doses of Inhaled ETD001 in People With Cystic Fibrosis
Sponsor:
Enterprise Therapeutics Ltd
Organization:
Enterprise Therapeutics Ltd
Study Overview
Official Title:
A Randomised Double-Blind Placebo Controlled Two-Part Study to Evaluate the Efficacy Safety Tolerability and Pharmacokinetics of a Repeat Dose of Inhaled ETD001 in People With Cystic Fibrosis
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is the first to give ETD001 to people with CF The study will be run in two parts Part A will assess if ETD001 is safe to give to people with CF and Part B will assess if ETD001 improves lung function The study drug is taken twice a day in Part A it is taken for 7 days and in Part B for 28 days In Part B there will be a separate period where dummy medicine is given for 28 days so the treatments can be compared
In Part A participants will receive 13 doses of either ETD001 or placebo 8 people will take part Participants will take up to 56 days to finish the study and make 5 outpatient visits
In Part B participants will receive 55 doses of ETD001 and 55 doses of placebo 32 people will take part Participants will take up to 140 days to finish the study and will make 8 outpatient visits
Study assessments include physical examinations vital signs heart traces bloodurine samples breathing tests and health questionnaires
In Part A participants will receive 13 doses of either ETD001 or placebo 8 people will take part Participants will take up to 56 days to finish the study and make 5 outpatient visits
In Part B participants will receive 55 doses of ETD001 and 55 doses of placebo 32 people will take part Participants will take up to 140 days to finish the study and will make 8 outpatient visits
Study assessments include physical examinations vital signs heart traces bloodurine samples breathing tests and health questionnaires
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None