A Phase 1 Clinical Study in Healthy Participants
ConditionHV
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorShanghai Argo Biopharmaceutical Co., Ltd.
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- BW-40202 injection or Placebo
- BW-40202 injection or Placebo
- BW-40202 injection or Placebo
- BW-40202 injection or Placebo
- BW-40202 injection or Placebo
Treatment groups
40 Participants
are divided into 5 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov