First‑in‑human test of ARD001 in healthy adults and people with hemophilia A

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a first‑in‑human interventional study testing ARD001. Phase 1 enrolls healthy adult participants who will receive a single dose of ARD001 or placebo to assess safety, pharmacokinetics, coagulation effects, and antibody development. Depending on safety and regulatory approvals, Phase 2 would evaluate multiple dosing in adults with hemophilia A to identify dose regimens for future trials. The trial aims to determine whether ARD001 can be administered safely and at doses suitable for further development. Primary results will inform next steps in development for people with hemophilia A.

Why it matters

Who can join: the full rules

Phase 1 Inclusion Criteria:

* Healthy adults within the specified age and body-weight ranges
* Able and willing to provide informed consent
* Considered healthy based on medical history, physical examination, vital signs, electrocardiogram and laboratory assessments
* Other essential criteria from the approved protocol

Phase 1 Exclusion Criteria:

* History of severe drug or food allergy, or known allergy to ARD001 or its components
* Acute infection within 14 days before dosing or fever on the planned dosing day
* Clinically significant cardiovascular, coagulation, hepatic, renal or other medical abnormality
* Recent use of prohibited medications within the protocol-defined washout periods
* Other major exclusions from the approved protocol

Where it's running

• SingHealth Investigational Medicine Unit
  Singapore, Singapore Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.