NCT06917482

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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Shanghai Argo Biopharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteers Only

Interventions

Type	Name	Description
DRUG	BW-40202 injection	BW-40202 is a conjugate drug, dosage form is solution for injection and route of administration is subcutaneous injection
OTHER	Sodium Chloride	Placebo (sodium chloride injection) will be administered as Subcutaneous injection

Timeline

• Start date: 2025-06-30
• Primary completion: 2026-07-31
• Completion: 2026-12-31
• First posted: 2025-04-08
• Last updated: 2025-07-25

Locations

2 sites across 1 country: Australia