BW-41012 injection or PlaceboBW-41012 injection or PlaceboBW-41012 injection or PlaceboBW-41012 injection or PlaceboBW-41012 injection or Placebo
BW-41012 injection or Placebo: BW-41012 injection or Placebo dosage form is solution for injection and route of administration is subcutaneous injection
BW-41012 injection or Placebo: BW-41012 injection or Placebo dosage form is solution for injection and route of administration is subcutaneous injection
BW-41012 injection or Placebo: BW-41012 injection or Placebo dosage form is solution for injection and route of administration is subcutaneous injection
BW-41012 injection or Placebo: BW-41012 injection or Placebo dosage form is solution for injection and route of administration is subcutaneous injection
BW-41012 injection or Placebo: BW-41012 injection or Placebo dosage form is solution for injection and route of administration is subcutaneous injection
Study 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
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
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
Primary outcome measure(s)
Primary endpoints — up to 24 hours Incidence and severity of adverse events (AEs), serious adverse events (SAEs), and the changes in clinical laboratory tests
Trial sites (1)
Facility
City
Region
Status
Argo Investigative Site
Perth
Western Australia
Recruiting
More Shanghai Argo Biopharmaceutical Co., Ltd. trials in Australia
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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