Actively Recruiting
A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose of BW-50218 in Healthy Chinese Participants
Led by Shanghai Argo Biopharmaceutical Co., Ltd. · Updated on 2026-06-04
24
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single dose of BW-50218 in healthy Chinese adults. This Phase 1 study aims to understand how this drug behaves in the body and its effects, involving participants aged 18 to 60 years who are generally healthy. Participants will receive one of several single doses of BW-50218 injection or a saline placebo. The study uses a randomized, double-blind design to compare different doses of BW-50218 against placebo. Each participant will receive only one dose, and the effects will be monitored over time. During the study, researchers will conduct various assessments including blood tests for hematology and chemistry, urinalysis, vital signs, ECGs, and physical exams from baseline to Day 360 after dosing. They will track adverse events and measure drug levels in plasma and urine up to Day 8. Participants will be closely monitored throughout the study duration, which lasts about one year, to evaluate the drug’s safety and how the body processes it.
CONDITIONS
Brief Title
A Phase 1 Study of Single-Dose BW-50218 in Healthy Chinese Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Capable of providing written informed consent and complying with all study procedures for the duration of the study.
- Body weight over 50 kg for males and over 45 kg for females.
- Body mass index (BMI) within a range considered appropriate for study participation by the investigator.
- Female participants must be non-pregnant, non-lactating, and either of non-childbearing potential or using highly effective contraception.
- Male participants with partners of childbearing potential must agree to use effective contraception.
You will not qualify if you...
- Any clinically significant chronic medical condition or abnormality in physical examination that makes the participant unsuitable.
- Recent hospitalization or significant acute medical event.
- History of cancer or any long-term medical condition considered clinically relevant.
- Clinical laboratory findings outside the normal range deemed clinically significant at screening or Day -1.
- Positive test for hepatitis B, hepatitis C, or HIV.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 8 days
Participants receive a single dose of BW-50218 injection or saline placebo. Safety, tolerability, pharmacokinetics, and pharmacodynamics are assessed.
1 baseline visit and multiple follow-up visits up to Day 8
Duration - Up to 360 days
Participants are monitored for safety and clinical outcomes including blood tests, vital signs, ECG, and physical examinations for up to 360 days after dosing.
Multiple visits over 12 months post dose
Trial Site Locations
Total: 1 location
1
Argo Investigative Site
Shanghai, China
Actively Recruiting
Research Team
Z
Zhi Hua
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here