A Phase 1/2 interventional study of ARD001 and Placebo in Hemophilia A and Healthy Adult Participants, sponsored by Arditus Pte Ltd. Recruiting at 1 site in Singapore. Open to male participants aged 21 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Arditus Pte Ltd · Phase 1/2, Interventional, and Treatment
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.
844 studies on the registry are indexed under Hemophilia A; 138 are open to participants now.
This study's planned enrollment of 20 is below the median of 30 across 499 interventional studies indexed under Hemophilia A.
Browse Hemophilia A studies →This is the only study on the registry with Arditus Pte Ltd as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Phase 1 Inclusion Criteria:
Phase 1 Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Other: Placebo
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
Biological: 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
The corresponding placebo will be administered subcutaneously as a single dose in Phase 1
Phase 1: Number of Participants With Treatment-Emergent Adverse Events, Serious Adverse Events, and Adverse Events of Special Interest
Number and percentage of participants with treatment-emergent adverse events, serious adverse events, and adverse events of special interest will be summarised.
Time frame: From first dose through Day 29 for Cohort A1 and Day 113 for Cohorts A2 and A3.
Observed Body Weight and Change From Baseline
Observed body weight values and changes from baseline will be summarized.
Time frame: Baseline and protocol-specified post-dose assessment time points through Day 29 for Cohort A1 and Day 113 for Cohorts A2 and A3.
Number of Participants With Clinically Significant Changes From Baseline in Hematology Parameters
Hematology assessments include white blood cell count with differential (neutrophils, lymphocytes, monocytes, eosinophils and basophils), red blood cell count and indices (mean corpuscular volume, mean corpuscular hemoglobin and mean corpuscular hemoglobin concentration), hemoglobin, and platelet count. The number of participants with clinically significant changes from baseline in hematology parameters will be summarized. Clinical significance will be determined by the investigator.
Time frame: At baseline and at protocol-specified post-dose assessment time points through Day 29 for Cohort A1 and Day 113 for Cohorts A2 and A3.
Number of Participants With Clinically Significant Changes From Baseline in Serum Chemistry Parameters
Serum chemistry assessments include creatinine, blood urea nitrogen, sodium, potassium, magnesium, phosphate, calcium, chloride, bicarbonate, fasting blood glucose, high-density lipoprotein, low-density lipoprotein, triglycerides, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, total and direct bilirubin, thyroid-stimulating hormone, free thyroxine, lactate dehydrogenase, creatine kinase, C-reactive protein, and uric acid. The number of participants with clinically significant changes from baseline in serum chemistry parameters will be summarized. Clinical significance will be determined by the investigator.
Time frame: At baseline and at protocol-specified post-dose assessment time points through Day 29 for Cohort A1 and Day 113 for Cohorts A2 and A3.
Number of Participants With Clinically Significant Changes From Baseline in Urinalysis Parameters
Urinalysis assessments include dipstick measurements of pH, protein, glucose, ketone, and blood, with reflex comprehensive urinalysis if abnormal as specified in the protocol. The number of participants with clinically significant changes from baseline in urinalysis parameters will be summarized. Clinical significance will be determined by the investigator.
Time frame: At baseline and at protocol-specified post-dose assessment time points through Day 29 for Cohort A1 and Day 113 for Cohorts A2 and A3.
Number of Participants With Clinically Significant Changes From Baseline in Coagulation Parameters
Coagulation assessments include prothrombin time (PT), international normalized ratio (INR), activated partial thromboplastin time (aPTT), fibrinogen, D-dimer, and thrombin time. The number of participants with clinically significant changes from baseline in coagulation parameters will be summarized. Clinical significance will be determined by the investigator.
Time frame: At baseline and at protocol-specified post-dose assessment time points through Day 29 for Cohort A1 and Day 113 for Cohorts A2 and A3.
Observed Values and Change From Baseline in Systolic Blood Pressure
Observed systolic blood pressure values and changes from baseline will be summarised.
Time frame: At baseline and at protocol-specified post-dose assessment time points through Day 29 for Cohort A1 and Day 113 for Cohorts A2 and A3.
Observed Values and Change From Baseline in Diastolic Blood Pressure
Time frame: At baseline and at protocol-specified post-dose assessment time points through Day 29 for Cohort A1 and Day 113 for Cohorts A2 and A3.
Observed Values and Change From Baseline in Pulse Rate
Time frame: At baseline and at protocol-specified post-dose assessment time points through Day 29 for Cohort A1 and Day 113 for Cohorts A2 and A3.
Observed Values and Change From Baseline in Respiratory Rate
Time frame: At baseline and at protocol-specified post-dose assessment time points through Day 29 for Cohort A1 and Day 113 for Cohorts A2 and A3.
Observed Values and Change From Baseline in Body Temperature
Time frame: At baseline and at protocol-specified post-dose assessment time points through Day 29 for Cohort A1 and Day 113 for Cohorts A2 and A3.
Observed Values and Change From Baseline in PR Interval
Observed PR interval values and changes from baseline obtained from protocol-specified 12-lead electrocardiograms will be summarised.
Time frame: At baseline and at protocol-specified post-dose assessment time points through Day 29 for Cohort A1 and Day 113 for Cohorts A2 and A3.
Observed Values and Change From Baseline in QRS Duration
Observed QRS duration values and changes from baseline obtained from protocol-specified 12-lead electrocardiograms will be summarised.
Time frame: At baseline and at protocol-specified post-dose assessment time points through Day 29 for Cohort A1 and Day 113 for Cohorts A2 and A3.
Observed Values and Change From Baseline in QT Interval
Observed uncorrected QT interval values and changes from baseline obtained from protocol-specified 12-lead electrocardiograms will be summarised.
Time frame: At baseline and at protocol-specified post-dose assessment time points through Day 29 for Cohort A1 and Day 113 for Cohorts A2 and A3.
Observed Values and Change From Baseline in QTcF Interval
Observed QT interval values corrected using Fridericia's formula and changes from baseline obtained from protocol-specified 12-lead electrocardiograms will be summarised.
Time frame: At baseline and at protocol-specified post-dose assessment time points through Day 29 for Cohort A1 and Day 113 for Cohorts A2 and A3.
Maximum Observed Serum Concentration of ARD001
Maximum observed serum concentration (Cmax) of ARD001 derived using noncompartmental analysis.
Time frame: From pre-dose through protocol-specified pharmacokinetic sampling through Day 29 for Cohort A1 and Day 113 for Cohorts A2 and A3.
Time to Maximum Observed Serum Concentration of ARD001
Area under the serum concentration-time curve from time zero to the last quantifiable concentration (AUC0-last) of ARD001 derived using noncompartmental analysis.
Time frame: Time of maximum observed serum concentration (Tmax) of ARD001 derived using noncompartmental analysis.
Area Under the Serum Concentration-Time Curve Extrapolated to Infinity
Area under the serum concentration-time curve from time zero extrapolated to infinity (AUC0-inf) of ARD001 derived using noncompartmental analysis.
Time frame: From pre-dose through protocol-specified pharmacokinetic sampling through Day 29 for Cohort A1 and Day 113 for Cohorts A2 and A3.
Mean Residence Time From Time Zero to Infinity of ARD001
Mean residence time from time zero to infinity (MRT0-inf) of ARD001 derived using noncompartmental analysis.
Time frame: From pre-dose through protocol-specified pharmacokinetic sampling through Day 29 for Cohort A1 and Day 113 for Cohorts A2 and A3.
Lag Time Before the First Measurable Serum Concentration of ARD001
Time before the first measurable non-zero serum concentration (Tlag) of ARD001 derived using noncompartmental analysis.
Time frame: From pre-dose through protocol-specified pharmacokinetic sampling through Day 29 for Cohort A1 and Day 113 for Cohorts A2 and A3.
Terminal Elimination Rate Constant of ARD001
Apparent terminal elimination rate constant (λz) of ARD001 derived from the terminal portion of the serum concentration-time profile using noncompartmental analysis.
Time frame: From pre-dose through protocol-specified pharmacokinetic sampling through Day 29 for Cohort A1 and Day 113 for Cohorts A2 and A3.
Apparent Terminal Elimination Half-Life of ARD001
Apparent terminal elimination half-life (t1/2) of ARD001 derived using noncompartmental analysis.
Time frame: From pre-dose through protocol-specified pharmacokinetic sampling through Day 29 for Cohort A1 and Day 113 for Cohorts A2 and A3.
Apparent Volume of Distribution During the Terminal Phase of ARD001
Apparent volume of distribution during the terminal phase following subcutaneous administration (Vz/F) of ARD001 derived using noncompartmental analysis.
Time frame: From pre-dose through protocol-specified pharmacokinetic sampling through Day 29 for Cohort A1 and Day 113 for Cohorts A2 and A3.
Apparent Clearance of ARD001
Apparent clearance following subcutaneous administration (CL/F) of ARD001 derived using noncompartmental analysis.
Time frame: From pre-dose through protocol-specified pharmacokinetic sampling through Day 29 for Cohort A1 and Day 113 for Cohorts A2 and A3.
Area Under the Serum Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration
Area under the serum concentration-time curve from time zero to the last quantifiable concentration (AUC0-last) of ARD001 derived using noncompartmental analysis.
Time frame: From pre-dose through protocol-specified pharmacokinetic sampling through Day 29 for Cohort A1 and Day 113 for Cohorts A2 and A3.
Number of Participants With Treatment-Emergent Anti-Drug Antibodies to ARD001
Number and percentage of participants with treatment-induced or treatment-boosted binding anti-drug antibodies to ARD001.
Time frame: From baseline through Day 29 for Cohort A1 and Day 113 for Cohorts A2 and A3.
Time to First Detection of Anti-Drug Antibodies to ARD001
Time from first dose to the first scheduled post-baseline sample with a positive binding anti-drug antibody result.
Time frame: From first dose through Day 29 for Cohort A1 and Day 113 for Cohorts A2 and A3.
Anti-Drug Antibody Titre to ARD001
Binding anti-drug antibody titre in participants with a positive anti-drug antibody result.
Time frame: From baseline through Day 29 for Cohort A1 and Day 113 for Cohorts A2 and A3.
Persistence of Anti-Drug Antibodies to ARD001
Persistence of binding anti-drug antibodies to ARD001 based on positive results at protocol-specified post-dose assessment time points.
Time frame: From baseline through Day 29 for Cohort A1 and Day 113 for Cohorts A2 and A3.
Plan to share: Undecided
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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