Ignite Creation Date:
2024-10-25 @ 8:02 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06600425
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-06
Brief Title:
A Study to Assess the Safety Tolerability Ciliary Rescue and Pharmacodynamics of RCT1100 in Adults with PCD
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 1b Single-Center Open-Label Study to Assess the Safety Tolerability Ciliary Rescue and Pharmacodynamics of RCT1100 in Adults with Primary Ciliary Dyskinesia Caused by Pathogenic Mutations in the DNAI1 Gene
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is the second in-human study with RCT1100 and is designed to provide safety tolerability and preliminary efficacy data for future clinical studies
Detailed Description:
The primary objective of this study is to assess the safety tolerability ciliary rescue pharmacodynamic biomarkers and preliminary efficacy of RCT1100 following multiple doses of inhaled RCT1100 administered via nebulizer to participants with Primary Ciliary Dyskinesia caused by disease-causing mutations in the DNAI1 gene
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None