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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-30

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Volunteers Only

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Arm1: Single dose of BW-40202

6 out of 8 participants randomized to cohort 1 will receive BW-40202

Group Type ACTIVE_COMPARATOR

BW-40202 injection

Intervention Type DRUG

BW-40202 is a conjugate drug, dosage form is solution for injection and route of administration is subcutaneous injection

Arm2: Single dose of BW-40202

If deemed safe and tolerable by Safety Review Committee, dose level will escalate to cohort , 6 out of 8 participants within cohort 2 will be randomized to receive BW-40202

Group Type ACTIVE_COMPARATOR

BW-40202 injection

Intervention Type DRUG

BW-40202 is a conjugate drug, dosage form is solution for injection and route of administration is subcutaneous injection

Arm3: Single dose of BW-40202

If deemed safe and tolerable by Safety Review Committee, dose level will escalate to cohort 3, 6 out of 8 participants within cohort 3 will be randomized to receive BW-40202

Group Type ACTIVE_COMPARATOR

BW-40202 injection

Intervention Type DRUG

BW-40202 is a conjugate drug, dosage form is solution for injection and route of administration is subcutaneous injection

Arm4: Single dose of BW-40202

If deemed safe and tolerable by Safety Review Committee, dose level will escalate to cohort 4, 6 out of 8 participants within cohort 4 will be randomized to receive BW-40202

Group Type ACTIVE_COMPARATOR

BW-40202 injection

Intervention Type DRUG

BW-40202 is a conjugate drug, dosage form is solution for injection and route of administration is subcutaneous injection

Arm5: Single dose of BW-40202

If deemed safe and tolerable by Safety Review Committee, dose level will escalate to cohort 5, 6 out of 8 participants within cohort 5 will be randomized to receive BW-40202

Group Type ACTIVE_COMPARATOR

BW-40202 injection

Intervention Type DRUG

BW-40202 is a conjugate drug, dosage form is solution for injection and route of administration is subcutaneous injection

Arm 6: Placebo

There will be 2 participants within each cohort be randomized to receive placebo.

Group Type PLACEBO_COMPARATOR

Sodium Chloride

Intervention Type OTHER

Placebo (sodium chloride injection) will be administered as Subcutaneous injection

Interventions

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BW-40202 injection

BW-40202 is a conjugate drug, dosage form is solution for injection and route of administration is subcutaneous injection

Intervention Type DRUG

Sodium Chloride

Placebo (sodium chloride injection) will be administered as Subcutaneous injection

Intervention Type OTHER

Eligibility Criteria

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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 \<body weight ≤100 kg.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes