A Study to Assess the Safety and Effects of the Investigational Drug BW-40202 in Healthy Volunteers
Launched by SHANGHAI ARGO BIOPHARMACEUTICAL CO., LTD. · Mar 31, 2025
Trial Information
Current as of July 09, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new drug called BW-40202 to see if it is safe for healthy adults. The drug will be given as an injection under the skin, and the trial will compare five different doses of BW-40202 with a placebo, which is a harmless saltwater solution. Healthy volunteers aged between 18 and 60 years old who meet certain criteria, like having a healthy weight and no significant medical conditions, may be eligible to participate.
Participants will be divided into five groups, with most receiving the drug and a few receiving the placebo. Trained staff will administer the injections, and safety checks will be conducted before moving to higher doses. If you decide to participate, you can expect close monitoring and support throughout the study. It's important to note that this trial is not yet recruiting participants, so there may be a wait before anyone can join.
Gender
ALL
Eligibility criteria
- Key inclusion criteria:
- • 1. Must have given written informed consent and be able to comply with all study requirements.
- • 2. Males or females aged 18 to 60 years old, inclusive, at the time of informed consent.
- • 3. BMI ≥18 and ≤32 kg/m2 with 50 kg \<body weight ≤100 kg.
- Key exclusion criteria:
- • 1. 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.
- • 2. Hospitalization for any reason within 60 days prior to screening.
- • 3. Any clinically significant acute condition such as fever (\>38 degree centigrade) or acute respiratory illness within 14 days of study drug administration.
- • 4. 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).
- • 5. 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.
- • 6. International normalized ratio (INR) above 1.2 × ULN at screening or Day -1.
- • 7. Single 12-lead electrocardiogram (ECG) with clinically significant abnormalities at screening or Day -1, asdetermined by the clinical investigator.
- • 8. History or clinical evidence of alcohol abuse,
- • 9. History or clinical evidence of drug abuse, within the 12 months before screening.
- • 10. Donated or lost \>200 mL of blood within 30 days prior to screening.
About Shanghai Argo Biopharmaceutical Co., Ltd.
Shanghai Argo Biopharmaceutical Co., Ltd. is a leading biopharmaceutical company dedicated to the research, development, and commercialization of innovative therapeutics. With a strong focus on addressing unmet medical needs, the company leverages advanced biotechnological platforms to develop cutting-edge treatments in areas such as oncology, autoimmune diseases, and infectious diseases. Committed to enhancing patient outcomes, Shanghai Argo Biopharmaceutical adheres to the highest standards of clinical research and regulatory compliance, fostering collaborations with global partners to accelerate the delivery of safe and effective therapies to the market.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Trial Officials
Feng Fan, MD. Ph.D
Study Director
Shanghai Argo Biopharmaceutical Co., Ltd.
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported