NCT04416126

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Arcturus Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Ornithine Transcarbamylase Deficiency

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-06-01
• Primary completion: 2020-12-09
• Completion: 2020-12-09
• First posted: 2020-06-04
• Last updated: 2023-11-08

Locations

1 site across 1 country: New Zealand

Regulatory

• FDA-regulated drug study