NCT07787091RecruitingPhase 1/2
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
Source: ClinicalTrials.gov · Last updated 28 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 2 Aug 2026
- Start date
- 19 Aug 2026
- Primary completion date
- Mar 2027
- Lead sponsor
- Arditus Pte Ltd
- Diseases
- Haemophilia
- NCT number
- NCT07787091
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 20
- From 19 Aug 2026 to the primary completion date, Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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
Age in the registry: 21 years to 45 years · Sex: Male · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| SingHealth Investigational Medicine Unit Coordinator of this site? Confirm its status | Singapore | Singapore | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.