Actively Recruiting
A Study to Assess the Safety and Effects of the Investigational Drug BW-40202 in Healthy Volunteers
Led by Shanghai Argo Biopharmaceutical Co., Ltd. · Updated on 2025-07-25
40
Participants Needed
2
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 different doses of BW-40202 compared to a placebo (saltwater solution). Participants will be divided into five groups, with each group receiving a different dose of BW-40202 or placebo. In each group, eight people will be randomly assigned to receive either the drug (6 people) or placebo (2 people). The Safety Review Committee will review the safety data before increasing the dose for the next group. Study nurses or trained staff will give the injections. Pharmacy staff will keep records of how much drug each participant receives, any returned or destroyed doses, and any changes from the planned dosing schedule. These records will be securely stored and available for review.
CONDITIONS
Official Title
A Study to Assess the Safety and Effects of the Investigational Drug BW-40202 in Healthy Volunteers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided written informed consent and can follow study requirements
- Male or female aged 18 to 60 years at consent
- Body mass index (BMI) between 18 and 32 kg/m2
- Body weight between 50 and 100 kg
You will not qualify if you...
- Any significant chronic medical condition or abnormal lab results making participation unsuitable
- Hospitalization within 60 days before screening
- Fever over 38 degrees Celsius or acute respiratory illness within 14 days before study drug
- Systolic blood pressure 140 mmHg or higher, or diastolic 90 mmHg or higher at screening or Day -1
- Liver function test results above 1.2 times the upper normal limit at screening
- International normalized ratio (INR) above 1.2 times upper normal limit at screening or Day -1
- Significant abnormalities in electrocardiogram (ECG) at screening or Day -1
- History or evidence of alcohol abuse
- History or evidence of drug abuse within 12 months before screening
- Donated or lost more than 200 mL of blood within 30 days before screening
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Q-Pharm Pty Ltd.
Brisbane, Queensland, Australia, 4006
Actively Recruiting
2
Nucleus Network Pty Ltd
Melbourne, Victoria, Australia, 3004
Not Yet Recruiting
Research Team
D
Di Hu, M.sc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
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