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

Ornithine Transcarbamylase Deficiency Clinical Trial

Official title:
A Phase 1 Randomized, Double Blinded, Placebo Controlled, Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single Doses of ARCT-810 in Healthy Adult Subjects

Clinical Trial Summary

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

Clinical Trial Description

This is a single ascending dose study of ARCT-810 in which approximately 30 subjects are planned to be enrolled. The length of each study participant is approximately 8 weeks from screening to last study visit. Study participants will be allocated to one of the five different study groups (also called cohorts), to test different doses of ARCT-810. There will be 6 participants in each group. Within each cohort, subjects will be randomized 2:1 to receive ARCT-810 or placebo as an IV infusion. ;

Study Design

Related Conditions & MeSH terms

  • Ornithine Transcarbamylase Deficiency
Clinical Trial Details
NCT number NCT04416126
Study type Interventional
Source Arcturus Therapeutics, Inc.
Contact
Status Completed
Phase Phase 1
Start date June 1, 2020
Completion date December 9, 2020
View Details
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