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

Shanghai Argo Biopharmaceutical Co., Ltd.

Status and phase

Begins enrollment this month

Phase 1

Conditions

Healthy Volunteers Only

Treatments

Drug: BW-40202 injection

Other: Sodium Chloride

Study type

Interventional

Funder types

Industry

Identifiers

NCT06917482

BW-40202-1001

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key inclusion criteria:

Must have given written informed consent and be able to comply with all study requirements.
Males or females aged 18 to 60 years old, inclusive, at the time of informed consent.
BMI ≥18 and ≤32 kg/m2 with 50 kg <body weight ≤100 kg.

Key exclusion criteria:

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.
Hospitalization for any reason within 60 days prior to screening.
Any clinically significant acute condition such as fever (>38 degree centigrade) or acute respiratory illness within 14 days of study drug administration.
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).
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.
International normalized ratio (INR) above 1.2 × ULN at screening or Day -1.
Single 12-lead electrocardiogram (ECG) with clinically significant abnormalities at screening or Day -1, asdetermined by the clinical investigator.
History or clinical evidence of alcohol abuse,
History or clinical evidence of drug abuse, within the 12 months before screening.
Donated or lost >200 mL of blood within 30 days prior to screening.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Triple Blind

40 participants in 6 patient groups, including a placebo group

Arm1: Single dose of BW-40202

Active Comparator group

Description:

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

Treatment:

Drug: BW-40202 injection

Arm2: Single dose of BW-40202

Active Comparator group

Description:

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

Treatment:

Drug: BW-40202 injection

Arm3: Single dose of BW-40202

Active Comparator group

Description:

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

Treatment:

Drug: BW-40202 injection

Arm4: Single dose of BW-40202

Active Comparator group

Description:

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

Treatment:

Drug: BW-40202 injection

Arm5: Single dose of BW-40202

Active Comparator group

Description:

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

Treatment:

Drug: BW-40202 injection

Arm 6: Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Sodium Chloride