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Taking people in SingaporePhase 1/2

First safety study of ARD001 in healthy adults and people with hemophilia A

Tests the safety of ARD001, a possible hemophilia A medicine, in healthy adults.

Key facts

Who runs it
Arditus Pte Ltd
Where
Singapore, SingaporeSee the site
Trial code
Registry title
A First-in Human Study of ARD001 in Healthy Volunteers and People With Hemophilia A
Status
Recruiting
Phase
Phase 1/2
People taking part
20 people, planned
Started
19 Aug 2026
Expected to end
Mar 2027
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • ARD001
  • Placebo
Record updated
28 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for healthy adult men to receive one dose of ARD001 or placebo, to check its safety. A later part for adults with hemophilia A is not open yet.

Age
21 to 45 years
Sex
Men only
Disease stage
Phase 1 is for healthy adults. Phase 2, for adults with hemophilia A, is not currently open for enrollment.
Earlier treatment
Recent use of prohibited medications within the protocol-defined washout periods is not allowed.

Main reasons for not taking part

  • Severe drug or food allergy, or known allergy to ARD001 or its components
  • Acute infection within 14 days before dosing, or fever on the dosing day
  • Clinically significant heart, blood clotting, liver, kidney or other medical problem
  • Recent use of prohibited medications within the protocol-defined washout periods

The registry criteria, word for word

Show all 10 criteriaShow less

Other criteria

  • 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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 21 and 45 years old?

Where in Singapore

  • SingHealth Investigational Medicine UnitSingapore, SingaporeContact: Lavanya Lakshmi JeevaTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 2 groups in the trial

  • PlaceboPlacebo, for comparison

    In Phase 1, healthy adult participants randomized to placebo will receive a single subcutaneous dose of the corresponding placebo within one of the three sequential dose cohorts. No placebo treatment is planned for Phase 2

  • ARD001Treatment being tested

    In Phase 1, healthy adult participants randomized to ARD001 will receive a single subcutaneous dose of 0.01, 0.1, or 0.3 mg/kg in one of three sequential ascending-dose cohorts. In Phase 2, adults with hemophilia A are planned to receive multiple subcutaneous doses of ARD001. The Phase 2 dose and regimen will be defined in a protocol amendment before Phase 2 initiation

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Plain-language title
First safety study of ARD001 in healthy adults and people with hemophilia AGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 13 November 2026.
Fit questions
Built from NCT07787091, who can take part
Record updated
28 October 2026