BW-50218 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-50218 in Healthy Participants

This trial tests single ascending subcutaneous doses of BW-50218 in healthy adults to see if it is safe, well tolerated, and how the body handles the drug.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Shanghai Argo Biopharmaceutical Co., Ltd. (Industry-sponsored)
• Locations: 2 sites (Adelaide, South Australia and 1 other locations)
• Trial ID: NCT07401472 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-blind, placebo-controlled Phase 1 single-ascending-dose study in healthy adult volunteers. Participants receive subcutaneous BW-50218 or saline placebo in sequential dose cohorts with safety and PK/PD monitoring between dose levels. The study collects adverse events, clinical laboratory data, and pharmacokinetic and pharmacodynamic measurements over the dosing and follow-up periods. Dose escalation is driven by pre-specified safety criteria and investigator review.

Who should consider this trial

Good fit: Ideal candidates are healthy adults who meet the study weight/BMI criteria, are non-pregnant (or use effective contraception), and can comply with in-clinic dosing and follow-up requirements.

Not a fit: People with active medical conditions, recent hospitalization, abnormal clinically significant screening labs, or a history of relevant chronic disease are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the study could identify a safe dose range and pharmacokinetic profile that enables further testing of BW-50218 in patient populations.

How similar studies have performed: Single-ascending-dose phase 1 trials in healthy volunteers are a standard first step and have successfully characterized safety and PK for many novel drugs, though BW-50218 itself appears to be a novel compound without published human data.

Eligibility criteria

Inclusion Criteria:

* Capable of providing written informed consent and complying with all study procedures for the duration of the study.
* Body weight and 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.

Exclusion Criteria:

* Any medical condition, recent illness, or laboratory result that, in the investigator's opinion, may increase risk or interfere with participation in the study.
* Recent hospitalization or a significant acute medical event.
* History of cancer or any long-term medical condition that the study doctor considers clinically relevant.
* Clinical laboratory findings outside of range which are deemed clinically significant by the investigator at screening or Day -1.
* Positive test for hepatitis B, hepatitis C, or HIV.

Where this trial is running

Adelaide, South Australia and 1 other locations

• CMAX Clinical Research Pty Ltd — Adelaide, South Australia, Australia (Recruiting)
• Linear Early Fhase Limited — Nedlands, Western Australia, Australia (Not_yet_recruiting)

Study contacts

• Study coordinator: Zhi Hua

Conditions Healthy Participants Study