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Safety, Tolerability and Pharmacokinetics of ARCT-810 in Healthy Adult Subjects

NCT04416126 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-11-08

No results posted yet for this study

Summary

Determine the safety, tolerability and pharmacokinetics of single doses of ARCT-810 in healthy adult subjects.

Conditions

  • Ornithine Transcarbamylase Deficiency

Interventions

BIOLOGICAL

ARCT-810

ARCT-810 is an investigational medicinal product comprising OTC mRNA formulated in a lipid nanoparticle (LNP) under development.

OTHER

Placebo

The placebo for this study is 0.9% sterile saline.

Sponsors & Collaborators

  • Arcturus Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Christian Schwabe, MD · Auckland Clinical Studies (ACS) Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-01
Primary Completion
2020-12-09
Completion
2020-12-09
FDA Drug
Yes

Countries

  • New Zealand

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 NCT04416126 on ClinicalTrials.gov