HV
Conditions
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
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
DRUGBW-41012 injection or Placebo
BW-41012 injection or Placebo dosage form is solution for injection and route of administration is subcutaneous injection
Sponsors
Shanghai Argo Biopharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary endpoints | up to 24 hours | Incidence and severity of adverse events (AEs), serious adverse events (SAEs), and the changes in clinical laboratory tests |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary endpoints | up to 8 days | Assessment the PK parameters change * Maximum observed plasma concentration (Cmax) * Time to maximum plasma concentration (Tmax) * Terminal elimination half-life (t1/2) * Area under the plasma concentration-time curve from time zero to the time of last measurable concentration (AUClast) * Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) |
Countries
Australia
Contacts
CONTACTYing Zhang
Outcome results
None listed