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NCT Number: NCT07584876

A Phase 1 Clinical Study in Healthy Participants

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

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Key information

Conditions

HV

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Argo Investigative Site

Perth, Western Australia, Australia

Location status: Recruiting

About this study

This is a randomized, double-blind, placebo-controlled, single ascending dose (SAD) study of BW-41012 when administered subcutaneously to healthy participants. Approximately 40 men and women aged ≥18 to ≤65 years (inclusive) who fulfill the inclusion and exclusion criteria will be enrolled in 5 cohorts.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

BW-41012 injection or Placebo

Drug

BW-41012 injection or Placebo dosage form is solution for injection and route of administration is subcutaneous injection

Primary outcomes

  1. Primary endpoints

    Time frame: up to 24 hours

    Incidence and severity of adverse events (AEs), serious adverse events (SAEs), and the changes in clinical laboratory tests

Secondary outcomes

  1. Secondary endpoints

    Time frame: up to 8 days

    Assessment the PK parameters change

    • Maximum observed plasma concentration (Cmax)
    • Time to maximum plasma concentration (Tmax)
    • Terminal elimination half-life (t1/2)
    • Area under the plasma concentration-time curve from time zero to the time of last measurable concentration (AUClast)
    • Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf)

  2. Secondary endpoints

    Time frame: up to 360days

    Assessment the PD parameters change

    • Change from baseline in the level of factor XI
    • Change from baseline in the level of activated partial thromboplastin time

Study contacts

Contact information is provided by the study sponsor or research team.

Ying Zhang

CONTACT

[email protected]

+8618806137286

Sponsors and collaborators

Lead sponsor

Shanghai Argo Biopharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
May 13, 2026
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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