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A First-in Human Study of ARD001 in Healthy Volunteers and People With Hemophilia A
Sponsor: Arditus Pte Ltd
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.
Official title: 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
Key Details
Gender
MALE
Age Range
21 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2026-08
Completion Date
2027-03
Last Updated
2026-08-26
Healthy Volunteers
Yes
Conditions
Interventions
ARD001
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
Placebo
The corresponding placebo will be administered subcutaneously as a single dose in Phase 1
Locations (1)
SingHealth Investigational Medicine Unit
Singapore, Singapore