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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
40
BW-40202 injection or Placebo dosage form is solution for injection and route of administration is subcutaneous injection
BW-40202 injection or Placebo dosage form is solution for injection and route of administration is subcutaneous injection
BW-40202 injection or Placebo dosage form is solution for injection and route of administration is subcutaneous injection
Argo Investigative Site
Perth, Western Australia, Australia
Primary endpoints
Incidence and severity of adverse events (AEs), serious adverse events (SAEs), and the changes in clinical laboratory tests
Time frame: up to 24 hours
Secondary endpoints
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)
Time frame: up to 8 days
Secondary endpoints
Assessment the PD parameters change * Change from baseline in the level of factor XI * Change from baseline in the level of activated partial thromboplastin time
Time frame: up to 360days
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BW-40202 injection or Placebo dosage form is solution for injection and route of administration is subcutaneous injection
BW-40202 injection or Placebo dosage form is solution for injection and route of administration is subcutaneous injection