Clinical Trial

A Study to Assess the Safety and Effects of the Investigational Drug BW-40202 in Healthy Volunteers

Recruiting Phase 1
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Record status
This record was last updated July 25, 2025 (before its estimated July 31, 2026 completion). Its status may not reflect the trial's current state.
Summary
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-03-31.
Status change: Not Yet Recruiting → Recruiting 2025-07-22
Trial Details
NCT Number NCT06917482
Lead Sponsor Shanghai Argo Biopharmaceutical Co., Ltd.
Conditions Healthy Volunteers Only
Enrollment 40 participants
Start Date 2025-06-30
Primary Completion 2026-07-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-07-25