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A Study to Assess the Safety and Effects of the Investigational Drug BW-40202 in Healthy Volunteers
Sponsor: Shanghai Argo Biopharmaceutical Co., Ltd.
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2025-06-30
Completion Date
2026-12-31
Last Updated
2025-07-25
Healthy Volunteers
Yes
Conditions
Interventions
BW-40202 injection
BW-40202 is a conjugate drug, dosage form is solution for injection and route of administration is subcutaneous injection
Sodium Chloride
Placebo (sodium chloride injection) will be administered as Subcutaneous injection
Locations (2)
Q-Pharm Pty Ltd.
Brisbane, Queensland, Australia
Nucleus Network Pty Ltd
Melbourne, Victoria, Australia