Ignite Creation Date:
2024-05-06 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05712538
Status:
COMPLETED
Last Update Posted:
2023-12-04
First Post:
2023-01-26
Brief Title:
Safety Tolerability and Pharmacokinetics of ARCT-032 in Healthy Adult Subjects and Adults with Cystic Fibrosis
Sponsor:
Arcturus Therapeutics Inc
Organization:
Arcturus Therapeutics Inc
Study Overview
Official Title:
A Study in Two Parts Phase 1 a Randomized Double-blinded Placebo--controlled Single-ascending-dose Study in Healthy Adult Subjects and Phase 1b an Open-label Nested Divided-dose Study in Adults with Cystic Fibrosis to Assess the Safety Tolerability and Pharmacokinetics of ARCT-032
Status:
COMPLETED
Status Verified Date:
2023-11
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:
Determine the safety tolerability and pharmacokinetics of single doses of ARCT-032 in healthy adult subjects Phase 1 and of two doses in Adults with Cystic Fibrosis Phase 1b
Detailed Description:
Phase 1 of this study is a single ascending dose first-in-human study to determine the safety tolerability and pharmacokinetics PK of ARCT-032 After screening healthy adult participants will be randomized 31 to inhale a single dose of nebulized ARCT-032 or placebo There are 4 planned sequential dose cohorts After dosing participants will have follow-up assessments over a 4-week period
Phase 1b in adults with cystic fibrosis will enroll after Phase 1 is completed and safety data are reviewed Phase 1b is an open-label two-dose study in adults with cystic fibrosis to assess the safety tolerability and pharmacokinetics of ARCT-032 After completion of screening each participants will inhale two doses of nebulized ARCT-032 two days apart Participants will have follow-up assessments over a 4-week period
Phase 1b in adults with cystic fibrosis will enroll after Phase 1 is completed and safety data are reviewed Phase 1b is an open-label two-dose study in adults with cystic fibrosis to assess the safety tolerability and pharmacokinetics of ARCT-032 After completion of screening each participants will inhale two doses of nebulized ARCT-032 two days apart Participants will have follow-up assessments over a 4-week period
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