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

NCT06917482 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-07-25

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Shanghai Argo Biopharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Zhuo Chang, MD. Ph.D · Shanghai Argo Biopharmaceutical Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-06-30
Primary Completion
2026-07-31
Completion
2026-12-31

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06917482 on ClinicalTrials.gov