A First-in Human Study of ARD001 in Healthy Volunteers and People With Hemophilia A
A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Single-Ascending-Dose Study Investigating the Safety and Tolerability of ARD001 in Healthy Adult Subjects and a Phase 2 Open-Label, Multiple-Dose Study in Adult Subjects With Hemophilia A
Arditus Pte Ltd
20 participants
Aug 1, 2026
INTERVENTIONAL
Conditions
Summary
This study is evaluating ARD001, an investigational medicine being developed for the treatment of hemophilia A. In Phase 1, healthy adult participants will receive a single dose of ARD001 or placebo to assess its safety and tolerability, how it moves through the body, its effects on blood coagulation, and whether the body develops antibodies against it. If the Phase 1 results support further study and the required regulatory and ethics approvals are obtained, Phase 2 will evaluate repeated doses of ARD001 in adults with hemophilia A. Phase 2 is not currently open for enrollment. The study is designed to determine whether ARD001 can be administered with acceptable safety and to identify doses suitable for further clinical development.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
ARD001 will be administered subcutaneously as a single dose of 0.01, 0.1, or 0.3 mg/kg in Phase 1. A multiple-dose regimen is planned for Phase 2 and will be specified in a protocol amendment before Phase 2 initiation
The corresponding placebo will be administered subcutaneously as a single dose in Phase 1
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07787091