A Study to Evaluate the Pharmacodynamics and Safety of ARCT-810 in Participants With OTCD

NCT06488313 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2025-03-17

No results posted yet for this study

Summary

Evaluate the safety and pharmacodynamics of multiple doses of ARCT-810 in adolescent and adult participants with OTC deficiency.

Conditions

  • OTC Deficiency
  • Ornithine Transcarbamylase Deficiency
  • OTCD

Interventions

BIOLOGICAL

ARCT-810

ARCT-810 is an investigational medicinal product comprising Ornithine Transcarbamylase (OTC) messenger RNA (mRNA) formulated in a lipid nanoparticle (LNP).

Sponsors & Collaborators

  • Arcturus Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-04
Primary Completion
2026-06-01
Completion
2026-09-01
FDA Drug
Yes

Countries

  • United States

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 NCT06488313 on ClinicalTrials.gov