Status:
RECRUITING
A Study to Assess the Safety and Effects of the Investigational Drug BW-40202 in Healthy Volunteers
Lead Sponsor:
Shanghai Argo Biopharmaceutical Co., Ltd.
Conditions:
Healthy Volunteers Only
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
This study will test the safety of a new drug called BW-40202 in healthy adults. The drug is a clear liquid given as an injection under the skin (subcutaneous injection). The study will test five diff...
Eligibility Criteria
Inclusion
- Key inclusion criteria:
- Must have given written informed consent and be able to comply with all study requirements.
- Males or females aged 18 to 60 years old, inclusive, at the time of informed consent.
- BMI ≥18 and ≤32 kg/m2 with 50 kg \<body weight ≤100 kg.
- Key exclusion criteria:
- Any clinically significant chronic medical condition or clinically significant abnormality in laboratory parameters that, in the opinion of the investigator, makes the subject unsuitable for participation in the study.
- Hospitalization for any reason within 60 days prior to screening.
- Any clinically significant acute condition such as fever (\>38 degree centigrade) or acute respiratory illness within 14 days of study drug administration.
- Systolic blood pressure (more than equal to) 140 mmHg and/or diastolic blood pressure (more than equal to) 90 mmHg after at least 5 minutes resting (seated or supine) at screening and Day -1(Repeat blood pressure measurement will be allowed at the discretion of the investigator).
- Any liver function panel analyte value \> 1.2 × upper limits of normal (ULN) which includes aspartate transaminase (AST), alanine transaminase (ALT), total bilirubin (TBIL), alkaline phosphatase (ALP) and gamma-glutamyl transferase (GGT) at screening.
- International normalized ratio (INR) above 1.2 × ULN at screening or Day -1.
- Single 12-lead electrocardiogram (ECG) with clinically significant abnormalities at screening or Day -1, asdetermined by the clinical investigator.
- History or clinical evidence of alcohol abuse,
- History or clinical evidence of drug abuse, within the 12 months before screening.
- Donated or lost \>200 mL of blood within 30 days prior to screening.
Exclusion
Key Trial Info
Start Date :
June 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06917482
Start Date
June 30 2025
End Date
December 31 2026
Last Update
July 25 2025
Active Locations (2)
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1
Q-Pharm Pty Ltd.
Brisbane, Queensland, Australia, 4006
2
Nucleus Network Pty Ltd
Melbourne, Victoria, Australia, 3004