A Phase 1 Clinical Study in Healthy Participants

Recruiting now · Phase 1 · Has a placebo group

Conditions studied: HV

In brief

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered BW-41012 in Healthy Participants

Key facts

Study ID

NCT07584876

Run by

Shanghai Argo Biopharmaceutical Co., Ltd.

People needed

40

Starts

2026-05-29

Expected to finish

2028-01-31

Last updated by the study team

2026-07-09

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Must have given written informed consent and be able to comply with all study requirements
• Males or females aged 18 to 65 years old, inclusive, at the time of informed consent
• Body mass index (BMI) ≥18.0 and ≤32.0 kg/m2 and body weight ≥50.0 kg.
• APTT, PT, INR, and FXI activity within the normal range at screening
• Agree to avoid activities that can increase the risk of severe bleeding
• Female participants must be non-pregnant
• Male participants with female partners of child-bearing potential must agree to use acceptable methods of contraception from screening until 360 days following administration of the study drug

You may not qualify if…

• Any clinically significant chronic medical condition or clinically significant abnormality in laboratory parameters
• Any skin condition and/or tattoo
• Hospitalization for any reason within 60 days prior to screening
• History or presence of cancer
• Any clinically significant acute condition
• Systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg after at least 5 minutes resting
• Clinical laboratory findings outside of range
• Any liver function panel analyte value > 1.2 × upper limits of normal (ULN)
• Positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody
• Single 12-lead ECG with clinically significant abnormalities at screening or Day -1
• Use of an investigational agent
• .Used of prescription drugs
• History or clinical evidence of alcohol substance abuse
• History or clinical evidence of drug abuse
• Positive test for alcohol or drugs of abuse at screening or Day -1
• Donated or lost >200 mL of blood
• .Any conditions which, in the opinion of the Investigator

Where it is running

• Argo Investigative Site — Perth, Western Australia, Australia (enrolling)

Full record on ClinicalTrials.gov

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