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

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

Study Overview

• Status: Not yet recruiting
• Conditions: HV
• Intervention / Treatment: Drug: BW-40202 injection or Placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Ying Zhang; Phone Number: +8618806137286; Email: yingzhang@argobiopharma.com

Study Locations

• Australia
  • Western Australia
    • Perth, Western Australia, Australia
      • Argo Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1; BW-41012 (cohort 1, n=8)	Drug: BW-40202 injection or Placebo; BW-40202 injection or Placebo dosage form is solution for injection and route of administration is subcutaneous injection
Experimental: Cohort 2; BW-41012 (cohort 2, n=8)	Drug: BW-40202 injection or Placebo; BW-40202 injection or Placebo dosage form is solution for injection and route of administration is subcutaneous injection
Experimental: Cohort 3; BW-41012 (cohort 3, n=8)	Drug: BW-40202 injection or Placebo; BW-40202 injection or Placebo dosage form is solution for injection and route of administration is subcutaneous injection
Experimental: Cohort 4; BW-41012 (cohort 4, n=8)	Drug: BW-40202 injection or Placebo; BW-40202 injection or Placebo dosage form is solution for injection and route of administration is subcutaneous injection
Experimental: Cohort 5; BW-41012 (cohort 5, n=8)	Drug: BW-40202 injection or Placebo; BW-40202 injection or Placebo dosage form is solution for injection and route of administration is subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary endpoints	Incidence and severity of adverse events (AEs), serious adverse events (SAEs), and the changes in clinical laboratory tests	up to 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary endpoints	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)	up to 8 days
Secondary endpoints	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	up to 360days

Collaborators and Investigators

• Sponsor: Shanghai Argo Biopharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): May 15, 2026
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): January 31, 2028

Study Registration Dates

• First Submitted: April 26, 2026
• First Submitted That Met QC Criteria: May 7, 2026
• First Posted (Actual): May 13, 2026

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: BW-41012-1001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No