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NCT07584876
A Phase 1 Clinical Study in Healthy Participants
Conditions: HV
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 40
Sponsor: Shanghai Argo Biopharmaceutical Co., Ltd.
Location: Argo Investigative Site Perth Western Australia
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 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
Source: ClinicalTrials.gov (NCT07584876). StuddyBuddy aggregates publicly available trial information.