Clinical trial NCT06917482: A Study to Assess the Safety and Effects of the Investigational Drug BW-40202 in Healthy Volunteers
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Healthy Volunteers Only
Lead sponsor: Shanghai Argo Biopharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-04-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility 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 \<body weight ≤100 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.

Primary outcomes:
measure: Proportion of participants experiencing at least one treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) from baseline to Day 169. To determine the incidenc of TEAEs and SAEs.
timeFrame: From first participant enrolled until Day 169 post-dose of last participant
measure: Collecting the adverse events(AEs) up to D169 and the AEs will be categorized based on Medical Dictionary for Regulatory Activities (MedDRA) terms and clssified by System Organ Class (SOC) and Preferred Term (PT) for summary.
timeFrame: From first participant enrolled until Day 169 post-dose of last participant
measure: Grading the TEAE and SAE based on severity and number of TEAEs and SAEs will be listed based on severity from baseline to Day 169.
timeFrame: From first participant enrolled until Day 169 post-dose of last participant
measure: Hematology results (concentration of Hemoglobin, g/L; Platelets, 10^9/L; Red blood cell count, 10^12/L) at each time point, including changes from baseline to Day 169 post dose will be summarized by treatment group.
timeFrame: From first participant enrolled until Day 169 post-dose of last participant
measure: Coagulation results (Activated partial thermoplastic time, s; Prothrombin time, s) at each time point, including changes from baseline to Day 169 post dose will be summarized by treatment group.
timeFrame: From first participant enrolled until Day 169 post-dose of last participant
measure: Chemistry results (concentration of Albumin, g/L; Alkaline Phosphatase, U/L; Alanine Amintransferase, U/L; Aspartate Aminotransferase, U/L;Direct Billirubin umol/L) at each time point from baseline to Day 169 will be summarized by treatment group.
timeFrame: From first participant enrolled until Day 169 post-dose of last participant
measure: Urinalysis results（Epithelial cells, crystals, casts, bilirubin) at each time point, including change from baseline to Day 169 post dose will be summarized in the table by treatment group.
timeFrame: From first participant enrolled until Day 169 post-dose of last participant
measure: Vital signs (blood pressures, millimeters of mercury) changes from Baseline values to Day 169 post dose will be summarized in the table by treatment group.
timeFrame: From first participant enrolled until Day 169 post-dose of last participant
measure: Vital signs (heart rate, beats per minute) changes from Baseline values to Day 169 post dose will be summarized in the table by treatment group.
timeFrame: From first participant enrolled until Day 169 post-dose of last participant
measure: Vital signs (temperature,degrees Celsius) changes from Baseline values to Day 169 post dose will be summarized in the table by treatment group.
timeFrame: From first participant enrolled until Day 169 post-dose of last participant
measure: Changes in ECG (Mean heart rate, bpm; PR Interval,msec; QRS Duration, msec; QT interval, msec; RR interval, msec; QTcF Interval, msec; ) from Baseline to Day 169 post-dose will be summarized.
timeFrame: From first participant enrolled until Day 169 post-dose of last participant
measure: By subject data listings will be created for all physical examination parameters(general appearance, head, neck, skin and others) from baseline to Day 169 post dose..
timeFrame: From first participant enrolled until Day 169 post-dose of last participant
measure: Vital signs (respiratory rate, times per minute) changes from Baseline values to Day 169 post dose will be summarized in the table by treatment group.
timeFrame: From first participant enrolled until Day 169 post-dose of last participant
measure: Hematology results (White blood cell count and differential (absolute and % differential)) at each time point, including changes from baseline to Day 169 post dose will be summarized by treatment group.
timeFrame: From first participant enrolled until Day 169 post-dose of last participant
measure: Coagulation results (International normalized ratio) at each time point, including changes from baseline to Day 169 post dose will be summarized by treatment group.
timeFrame: From first participant enrolled until Day 169 post-dose of last participant
measure: Chemistry results (concentration of Calcium, mmol/L; creatine kinase, U/L; chloride, mmol/L; Gamma Glutamyl Transferase, U/L) at each time point from baseline to Day 169 will be summarized by treatment group.
timeFrame: From first participant enrolled until Day 169 post-dose of last participant
Secondary outcomes:
measure: maximum plasma concentration data (Cmax, ng/mL) of BW-40202 will be collected for all cohorts at the scheduled PK sampling timepoints.
timeFrame: From first patient enrolled until Day 8 post-dose of last patient.
measure: Time to Maximum plasma concentration (Tmax, hr) of BW-40202 will be calculated (hr). T max(Time to Maximum Concentration) is the time at which the maximum observed plasma drug concentration ( Cmax) occurs after drug administration.
timeFrame: From first patient enrolled until Day 8 post-dose of last patient.
measure: Calculate the Area Under the Plasma Concentration-Time Curve (AUC, hr*ng/mL), to estimate the AUC beyond the last observed time point (AUC0-∞), the AUC from 0 to 24 hours and AUC from 0 to 48 hours. The AUC represents the total drug exposure over time.
timeFrame: From first patient enrolled until Day 8 post-dose of last patient.
measure: Calculate the time required for the plama concentration of a drug to decrease by 50% in the elimination phase. Which is called terminal elimination half-life (t1/2, hr)
timeFrame: From first patient enrolled until Day 8 post-dose of last patient
measure: Calculate the Urine output (Aet, mg), Aet (total amount of drug excreted in urine during each time interval)
timeFrame: From first participant being enrolled until 24 hours post-dose of last enrolled participant
measure: Calculate the Urine output (Clr, L/h), the renal clearance measures the efficiency of drug elimination by the kidneys.
timeFrame: From first participant being enrolled until 24 hours post-dose of last enrolled participant
Other outcomes:
Locations:
Study officials:
affiliation: Shanghai Argo Biopharmaceutical Co., Ltd.
name: Feng Fan, MD. Ph.D
role: STUDY_DIRECTOR
References: