Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 4:23 PM
Ignite Modification Date:
2025-12-24 @ 4:23 PM
NCT ID:
NCT05526066
Brief Summary:
The primary objective is to evaluate the safety and tolerability of repeated doses of intravenously administered ARCT-810.
Detailed Description:
This study is a Phase 2, randomized, placebo-controlled study of ARCT-810 in people living with OTC deficiency 12 years of age and older. After an at least 4 week screening and diet stabilization period, participants will be randomized 3:1 to receive ARCT-810 or placebo. Following the first dose and safety evaluation, participants will receive up to an additional 5 doses of ARCT-810 or placebo, each separated by 14 days. The treatment period is followed by a 12-week observation period.
Study:
NCT05526066
Study Brief:
Protocol Section:
NCT05526066