A Phase 1 Clinical Study in Healthy Participants

NCT07584876 | Recruiting Phase 1

• 1 other identifier: BW-41012-1001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

HV

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Secondary endpoints

  up to 8 days

• Secondary endpoints

  up to 360days

Study Arms (5)

Cohort 1

EXPERIMENTAL

BW-41012 (cohort 1, n=8)

Drug: BW-41012 injection or Placebo

Cohort 2

EXPERIMENTAL

BW-41012 (cohort 2, n=8)

Drug: BW-41012 injection or Placebo

Cohort 3

EXPERIMENTAL

BW-41012 (cohort 3, n=8)

Drug: BW-41012 injection or Placebo

Cohort 4

EXPERIMENTAL

BW-41012 (cohort 4, n=8)

Drug: BW-41012 injection or Placebo

Cohort 5

EXPERIMENTAL

BW-41012 (cohort 5, n=8)

Drug: BW-41012 injection or Placebo

Interventions

BW-41012 injection or Placebo DRUG

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

Cohort 1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Shanghai Argo Biopharmaceutical Co., Ltd.: lead

Study Sites (1)

Argo Investigative Site

Perth, Western Australia, Australia

RECRUITING

Central Study Contacts

Ying Zhang

CONTACT

+8618806137286; yingzhang@argobiopharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2026
• First Posted: May 13, 2026
• Study Start: May 29, 2026
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): January 31, 2028
• Last Updated: July 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)