Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06429176
Status:
RECRUITING
Last Update Posted:
2024-05-24
First Post:
2024-05-15
Brief Title:
Safety Tolerability Pharmacokinetics and Preliminary Efficacy of SPL84 in Patients With Cystic Fibrosis
Sponsor:
SpliSense Ltd
Organization:
SpliSense Ltd
Study Overview
Official Title:
A Phase 2a Randomized Placebo-Controlled Double Blind Multiple Ascending Dose Study in Patients With Cystic Fibrosis Carrying the 3849 10 Kb C-T Mutation to Evaluate the Safety Tolerability Pharmacokinetics and Preliminary Efficacy of SPL84
Status:
RECRUITING
Status Verified Date:
2024-05
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:
The goal of this clinical trial is to learn if drug SPL84 is safe for adult patients with cystic fibrosis CF It will also learn if the drug works to treat works to treat CF with a specific mutation
The purpose of this research study is to
test the safety and effectiveness of multiple doses of the study drug SPL84
test how multiple doses of the drug are processed by the body
Researchers will compare drug SPL84 to a placebo a look-alike substance that contains no drug to see if drug SPL84 is safe and if it works to treat CF
Participants will
Take drug SPL84 or a placebo by inhalation every week for 9 weeks months Visit the clinic approximately 14 times over 175 weeks for checkups and tests
The purpose of this research study is to
test the safety and effectiveness of multiple doses of the study drug SPL84
test how multiple doses of the drug are processed by the body
Researchers will compare drug SPL84 to a placebo a look-alike substance that contains no drug to see if drug SPL84 is safe and if it works to treat CF
Participants will
Take drug SPL84 or a placebo by inhalation every week for 9 weeks months Visit the clinic approximately 14 times over 175 weeks for checkups and tests
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2024-511184-28 | EUDRACT_NUMBER | None | None |