Ignite Creation Date:
2024-07-17 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06488313
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-06-28
Brief Title:
A Study to Evaluate the Pharmacodynamics and Safety of ARCT-810 in Participants With OTCD
Sponsor:
Arcturus Therapeutics Inc
Organization:
Arcturus Therapeutics Inc
Study Overview
Official Title:
A Phase 2a Open-label Multiple Ascending Dose Study to Evaluate the Pharmacodynamics and Safety of ARCT-810 in Adolescent and Adult Participants With Ornithine Transcarbamylase Deficiency
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:
Evaluate the safety and pharmacodynamics of multiple doses of ARCT-810 in adolescent and adult participants with OTC deficiency
Detailed Description:
This a Phase 2a open-label study of ARCT-810 in participants 12 years of age and older living with OTC deficiency After a diet stabilization period of at least 4 weeks all participants will be enrolled to receive ARCT-810 every two weeks for up to five doses at one of three dose levels Clinic visits will occur during screening and at Days 1 15 29 36 43 57 60 71 and 85 During the study participants will remain on their current clinical management for OTC deficiency Dose escalation or cohort expansion may occur following completion of three participants at each dose level
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