Safety of BW-40202 injections in healthy adults
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered BW-40202 in Healthy Subjects
This will test whether different doses of the injected drug BW-40202 are safe for healthy adults.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Shanghai Argo Biopharmaceutical Co., Ltd. Industry-sponsored |
| Locations | 2 sites (Brisbane, Queensland and 1 other locations) |
| Trial ID | NCT06917482 on ClinicalTrials.gov |
What this trial studies
This Phase 1, single-ascending-dose trial gives BW-40202 or placebo as a subcutaneous injection to healthy adult volunteers. Participants are divided into five dose groups, and within each group six subjects receive the drug and two receive placebo by random assignment. A Safety Review Committee reviews accumulated safety data before raising the dose for the next group. Trained clinical and pharmacy staff will administer doses and keep secure records of dosing, returns, destructions, and any deviations from the planned schedule.
Who should consider this trial
Good fit: Healthy men and women aged 18–60 with BMI 18–32 and body weight between 50 and 100 kg who can give informed consent and comply with study procedures are ideal candidates.
Not a fit: People with significant chronic medical conditions, clinically significant abnormal labs, recent hospitalization or acute illness, or elevated blood pressure outside the study limits would be ineligible and unlikely to benefit from participation.
Why it matters
Potential benefit: If BW-40202 is shown to be safe at one or more doses, it would enable further studies that could ultimately lead to new treatment options.
How similar studies have performed: The single-ascending-dose, placebo-controlled design is a standard first-in-human approach that has successfully characterized safety and dosing for many investigational drugs, though BW-40202 itself remains unproven.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Brisbane, Queensland and 1 other locations
- Q-Pharm Pty Ltd. — Brisbane, Queensland, Australia (Recruiting)
- Nucleus Network Pty Ltd — Melbourne, Victoria, Australia (Not_yet_recruiting)
Study contacts
- Study coordinator: Di Hu, M.sc
- Email: di.hu@argobiopharma.com
- Phone: +86 15601969786
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.