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NCT06917482 | NOT YET RECRUITING | Healthy Volunteers Only

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

Shanghai Argo Biopharmaceutical Co., Ltd.

Brief 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.

Condition or disease

Healthy Volunteers Only

Intervention/treatment

BW-40202 injection

Sodium Chloride

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 40 participants
Masking : TRIPLE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2025-06-30
Estimated Primary Completion Date : 2026-07-31
Estimated Study Completion Date : 2026-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 60 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
Key inclusion criteria
  • 1. Must have given written informed consent and be able to comply with all study requirements.
  • 2. Males or females aged 18 to 60 years old, inclusive, at the time of informed consent.
  • 3. BMI ≥18 and ≤32 kg/m2 with 50 kg \
  • Key exclusion criteria
    • 1. Any clinically significant chronic medical condition or clinically significant abnormality in laboratory parameters that, in the opinion of the investigator, makes the subject unsuitable for participation in the study.
    • 2. Hospitalization for any reason within 60 days prior to screening.
    • 3. Any clinically significant acute condition such as fever (\>38 degree centigrade) or acute respiratory illness within 14 days of study drug administration.
    • 4. Systolic blood pressure (more than equal to) 140 mmHg and/or diastolic blood pressure (more than equal to) 90 mmHg after at least 5 minutes resting (seated or supine) at screening and Day -1(Repeat blood pressure measurement will be allowed at the discretion of the investigator).
    • 5. Any liver function panel analyte value \> 1.2 × upper limits of normal (ULN) which includes aspartate transaminase (AST), alanine transaminase (ALT), total bilirubin (TBIL), alkaline phosphatase (ALP) and gamma-glutamyl transferase (GGT) at screening.
    • 6. International normalized ratio (INR) above 1.2 × ULN at screening or Day -1.
    • 7. Single 12-lead electrocardiogram (ECG) with clinically significant abnormalities at screening or Day -1, asdetermined by the clinical investigator.
    • 8. History or clinical evidence of alcohol abuse,
    • 9. History or clinical evidence of drug abuse, within the 12 months before screening.
    • 10. Donated or lost \>200 mL of blood within 30 days prior to screening.
A Study to Assess the Safety and Effects of the Investigational Drug BW-40202 in Healthy Volunteers

Location Details

NCT06917482

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