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Study for Adolescents and Adults With Ornithine Transcarbamylase Deficiency to Evaluate Safety and Tolerability of ARCT-810

NCT05526066 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2025-09-26

No results posted yet for this study

Summary

The primary objective is to evaluate the safety and tolerability of repeated doses of intravenously administered ARCT-810.

Conditions

  • Ornithine Transcarbamylase Deficiency
  • OTC Deficiency
  • OTCD

Interventions

BIOLOGICAL

ARCT-810

ARCT-810 is messenger RNA (mRNA) coding for Ornithine Transcarbamylase (OTC) formulated in a lipid nanoparticle (LNP).

OTHER

Placebo

Normal Saline

Sponsors & Collaborators

  • Arcturus Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
12 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-17
Primary Completion
2024-10-31
Completion
2024-10-31
FDA Drug
Yes

Countries

  • Belgium
  • France
  • Italy
  • Spain
  • Sweden
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05526066 on ClinicalTrials.gov