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Recruiting NCT07584876

A Phase 1 Clinical Study in Healthy Participants

Phase I Interventional HV

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BW-41012 injection or Placebo, BW-41012 injection or Placebo, BW-41012 injection or Placebo, BW-41012 injection or Placebo.
Who it may be relevant to
Registry conditions: HV. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Australia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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

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.

Interventions

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

Primary outcome measures

  • Primary endpoints [Time frame: up to 24 hours]
Secondary outcome measures (2)
  • Secondary endpoints [Time frame: up to 8 days]
  • Secondary endpoints [Time frame: up to 360days]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Australia · 1 center
  • Argo Investigative Site — Perth

Identifiers

NCT: NCT07584876 · BW-41012-1001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗