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RNA Therapy
Phase 1b Study to Assess Safety, Tolerability, and Pharmacokinetics of ARCT-810 in Stable Adult Subjects With Ornithine Transcarbamylase Deficiency
Phase 1
Waitlist Available
Research Sponsored by Arcturus Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Summary
This trial tests ARCT-810, a new treatment for patients with a specific condition, to see if it is effective and well-tolerated. The treatment aims to help the body better process waste products.
Eligible Conditions
- Urea cycle disorder
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence, severity and dose-relationship of adverse events (AEs)
Secondary study objectives
AUC0-inf after single dose of ARCT-810
AUCExtrap after single dose of ARCT-810
CL after single dose of ARCT-810
+6 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ARCT-810Experimental Treatment1 Intervention
Ascending single doses of ARCT-810 administered intravenously
Group II: PlaceboPlacebo Group1 Intervention
Single doses of 0.9% Saline administered intravenously
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ARCT-810
2020
Completed Phase 1
~50
Find a Location
Who is running the clinical trial?
Arcturus Therapeutics, Inc.Lead Sponsor
12 Previous Clinical Trials
22,435 Total Patients Enrolled