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Recruiting 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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07584876). StuddyBuddy aggregates publicly available trial information.