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RNA Therapy

ARCT-810 for 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
Awards & highlights

Study Summary

This trial will test the safety and tolerability of a new drug for people with OTCD.

Eligible Conditions
  • Ornithine Transcarbamylase Deficiency

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence, severity and dose-relationship of adverse events (AEs)
Secondary outcome measures
AUC0-inf after single dose of ARCT-810
AUCExtrap after single dose of ARCT-810
CL after single dose of ARCT-810
+6 more

Trial 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
~30

Find a Location

Who is running the clinical trial?

Arcturus Therapeutics, Inc.Lead Sponsor
10 Previous Clinical Trials
22,222 Total Patients Enrolled
2 Trials studying Ornithine Transcarbamylase Deficiency
54 Patients Enrolled for Ornithine Transcarbamylase Deficiency

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Phase 1b Study to Assess Safety, Tolerability, and Pharmacokinetics of ARCT-810 in Stable Adult Subjects With Ornithine Transcarbamylase Deficiency
2020. "Phase 1b Study to Assess Safety, Tolerability, and Pharmacokinetics of ARCT-810 in Stable Adult Subjects With Ornithine Transcarbamylase Deficiency". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04442347.
All > Ornithine Transcarbamylase Deficiency
~3 spots leftby Apr 2025
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