Healthy Volunteers OnlyPhase 1NCT06917482
A Study to Assess the Safety and Effects of the Investigational Drug BW-40202 in Healthy Volunteers
A Phase 1 study testing BW-40202 injection and Sodium Chloride in people with Healthy Volunteers Only, run by Shanghai Argo Biopharmaceutical Co., Ltd. at 2 sites in Australia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers Only
- What is being tested?
- BW-40202 injection and Sodium Chloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesAustralia
- Study dates
- 30 Jun 2025to 31 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia2 sites, 2 recruiting
- Recruiting
Q-Pharm Pty Ltd.
Brisbane, Queensland, 4006
- Not yet recruiting
Nucleus Network Pty Ltd
Melbourne, Victoria, 3004
About this study
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
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).
Read more
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
- Being tested
- BW-40202 injection, Sodium Chloride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BW-40202 injectionDrug
BW-40202 is a conjugate drug, dosage form is solution for injection and route of administration is subcutaneous injection
Sodium ChlorideOther
Placebo (sodium chloride injection) will be administered as Subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Arm1: Single dose of BW-40202 | Active comparator | 6 out of 8 participants randomized to cohort 1 will receive BW-40202 Receives: Drug: BW-40202 injection |
| Arm2: Single dose of BW-40202 | Active comparator | 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 Receives: Drug: BW-40202 injection |
| Arm3: Single dose of BW-40202 | Active comparator | 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 Receives: Drug: BW-40202 injection |
| Arm4: Single dose of BW-40202 | Active comparator | 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 Receives: Drug: BW-40202 injection |
| Arm5: Single dose of BW-40202 | Active comparator | 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 Receives: Drug: BW-40202 injection |
| Arm 6: Placebo | Placebo comparator | There will be 2 participants within each cohort be randomized to receive placebo. Receives: Other: Sodium Chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Incidence of TEAEs (%) = (number of subjects with TEAEs/Total number of subjects) *100 Incidence of SAEs (%) = (number of subjects with SAEs/total number of subjects)*100
Measured: From first participant enrolled until Day 169 post-dose of last participant
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.
Adverse events (AEs) were coded using the latest MedDRA version available at the time of study commencement. All AEs were collected after drug administration and were considered TEAEs to be included in the summaries. Summary tables included the number of subjects (%) experiencing an event and the number of events. Subjects who experienced multiple AEs were only counted once in each category (system organ class [SOC] and preferred term [PT]), but all events were included in the event frequencies (categorical descriptive analysis).
The TEAE summaries included:
- Overall summary of TEAEs.
- TEAE summary by SOC and PT.
- TEAE summary of serious events by SOC and PT.
- TEAE summary of study-drug related events by SOC and PT. TEAE summary by SOC, PT, and Toxicity Grading.
- TEAE summary by SOC, PT, and relationship to study drug.
- TEAE summary of events leading to study discontinuation by SOC and PT.
- TEAE summary of Injection Site reactions.
Measured: From first participant enrolled until Day 169 post-dose of last participant
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.
Adverse events are graded based on severity:
Mild (Grade 1): No significant impact on daily activities Moderate (Grade 2): Some interference with daily activities Severe (Grade 3): Significant impact on function Life-threatening (Grade 4): Immediate risk of death Fatal (Grade 5): Resulted in death.
Severity distribution = (number of subjects with grade X TEAE/total TEAE cases) *100
Measured: From first participant enrolled until Day 169 post-dose of last participant
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.
The safety laboratory data will be summarized by visit and by treatment group, along with changes from baseline. The values that are below the lower limit or above the upper limit of the reference range will be flagged for safety. Those values or changes in values that are identified as being clinically significant will be flagged.
Measured: From first participant enrolled until Day 169 post-dose of last participant
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.
The safety laboratory data will be summarized by visit and by treatment group, along with changes from baseline. The values that are below the lower limit or above the upper limit of the reference range will be flagged for safety. Those values or changes in values that are identified as being clinically significant will be flagged.
Measured: From first participant enrolled until Day 169 post-dose of last participant
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.
The safety laboratory data will be summarized by visit and by treatment group, along with changes from baseline. The values that are below the lower limit or above the upper limit of the reference range will be flagged for safety. Those values or changes in values that are identified as being clinically significant will be flagged.
Measured: From first participant enrolled until Day 169 post-dose of last participant
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.
The safety laboratory data will be summarized by visit and by treatment group, along with changes from baseline. The values that are below the lower limit or above the upper limit of the reference range will be flagged for safety. Those values or changes in values that are identified as being clinically significant will be flagged.
Measured: From first participant enrolled until Day 169 post-dose of last participant
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.
Abnormal physical examination findings will be listed.
Measured: From first participant enrolled until Day 169 post-dose of last participant
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.
Abnormal physical examination findings will be listed.
Measured: From first participant enrolled until Day 169 post-dose of last participant
Vital signs (temperature,degrees Celsius) changes from Baseline values to Day 169 post dose will be summarized in the table by treatment group.
Abnormal physical examination findings will be listed.
Measured: From first participant enrolled until Day 169 post-dose of last participant
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.
12-lead ECGs will be summarized by visit and by treatment group, along with the changes from baseline.The summary of overall interpretation findings table presented counts and percentages for the reported results at Baseline and Day 169/time point. Result categories were ordered as 'Normal', 'Abnormal Not Clinically Significant (NCS)' and 'Abnormal Clinically Significant (CS)' (categorical descriptive analysis).
Measured: From first participant enrolled until Day 169 post-dose of last participant
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..
Abnormal physical examination findings will be listed.
Measured: From first participant enrolled until Day 169 post-dose of last participant
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.
Abnormal physical examination findings will be listed.
Measured: From first participant enrolled until Day 169 post-dose of last participant
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.
The safety laboratory data will be summarized by visit and by treatment group, along with changes from baseline. The values that are below the lower limit or above the upper limit of the reference range will be flagged for safety. Those values or changes in values that are identified as being clinically significant will be flagged.
Measured: From first participant enrolled until Day 169 post-dose of last participant
Coagulation results (International normalized ratio) at each time point, including changes from baseline to Day 169 post dose will be summarized by treatment group.
The safety laboratory data will be summarized by visit and by treatment group, along with changes from baseline. The values that are below the lower limit or above the upper limit of the reference range will be flagged for safety. Those values or changes in values that are identified as being clinically significant will be flagged.
Measured: From first participant enrolled until Day 169 post-dose of last participant
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.
The safety laboratory data will be summarized by visit and by treatment group, along with changes from baseline. The values that are below the lower limit or above the upper limit of the reference range will be flagged for safety. Those values or changes in values that are identified as being clinically significant will be flagged.
Measured: From first participant enrolled until Day 169 post-dose of last participant
Secondary outcomes (6)
maximum plasma concentration data (Cmax, ng/mL) of BW-40202 will be collected for all cohorts at the scheduled PK sampling timepoints.
- Collect Plasma Concentration Data Blood samples are collected at predetermined time points after drug administration. The drug concentration in plasma is measured at each time point.
- Plot the plasma concentration-time curve X-axis: time after drug administration y-axis: plasma drug concentration
- Identify the highest observed concentration locate the highest data point in the plasma concentration-time curve the corresponding drug concentration value is Cmax
Measured: From first patient enrolled until Day 8 post-dose of last patient.
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.
- Collect Plasma Concentration Data Blood samples are collected at predetermined time points after drug administration. The drug concentration in plasma is measured at each time point.
- Plot a Concentration-Time Curve The plasma drug concentration (C) is plotted on the Y-axis. Time post-dose (T) is plotted on the X-axis.
- Identify Cmax Determine the highest drug concentration observed in plasma. The corresponding time point is Tmax
Measured: From first patient enrolled until Day 8 post-dose of last patient.
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.
AUC (0-∞), Total drug exposure from time zero to infinity (extrapolated). The equation used to calculate Area Under the Plasma Concentration-Time Curve from Zero to Infinity AUC(0-∞) is based on the trapezoidal rule and extrapolation using the elimination rate constant (λz).
AUC(0-24), Total drug exposure form time zero to 24 hours. The equation used to calculate Area Under the Plasma Concentration-Time Curve from Zero to 24 Hours (AUC₀-₂₄) is based on the trapezoidal rule and is called the Linear Trapezoidal Rule.
AUC(0-48) , total drug exposure from time zero to 48 hours. The equation used to calculate Area Under the Plasma Concentration-Time Curve from Zero to 48 Hours AUC(0-48) is based on the trapezoidal rule and is called the Linear Trapezoidal Rule.
Measured: From first patient enrolled until Day 8 post-dose of last patient.
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)
- Identify the Terminal Elimination Phase Plot a plasma concentration-time curve (log scale on Y-axis, linear scale on X-axis). Focus on the terminal elimination phase, where the concentration follows first-order kinetics (a straight line on a semi-log graph).
- Calculate the Elimination Rate Constant (Ke) Use the slope of the terminal phase of the log-transformed concentration-time curve
- Calculate the t1/2 using formula: t1/2=ln2/ke=0.693/ke.
Measured: From first patient enrolled until Day 8 post-dose of last patient
Calculate the Urine output (Aet, mg), Aet (total amount of drug excreted in urine during each time interval)
Total amount of drug excreted in urine from time t1 to t2 hours (for each urine time interval) Aet1 - t2=Cut1-t2*Vut-t2, where Vut1-t2 = the volume of urine collected from t1 to t2 and Cu t1-t2 = the concentration of drug in the collected urine. Parameters of interest are Ae0-4, Ae4-12, and Ae12-24.
Measured: From first participant being enrolled until 24 hours post-dose of last enrolled participant
Calculate the Urine output (Clr, L/h), the renal clearance measures the efficiency of drug elimination by the kidneys.
Renal clearance calculated as CLr = CAe/Plasma AUC0-24. Ae=cumulative amount excreted in urine (mg). AUC0-24 = Area under the plasma concentration - timecurve from 0 to 24 hours (e.g. mg*h/mL)
Measured: From first participant being enrolled until 24 hours post-dose of last enrolled participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start30 Jun 2025
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Volunteers OnlyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Argo Biopharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zhuo Chang, MD. Ph.D, Study director, Shanghai Argo Biopharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06917482
- Sponsor's protocol ID
- BW-40202-1001
- Status last verified
- Jul 2025
- First submitted
- 10 Mar 2025
- Last updated
- 25 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06917482
- Acronym / sponsor ID
- BW-40202-1001
- Conditions
- Healthy Volunteers Only
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Shanghai Argo Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Jun 2025 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Arm1: Single dose of BW-40202 | Active comparator | Drug: BW-40202 injection6 out of 8 participants randomized to cohort 1 will receive BW-40202 |
| Arm2: Single dose of BW-40202 | Active comparator | Drug: BW-40202 injectionIf 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 |
| Arm3: Single dose of BW-40202 | Active comparator | Drug: BW-40202 injectionIf 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 |
| Arm4: Single dose of BW-40202 | Active comparator | Drug: BW-40202 injectionIf 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 |
| Arm5: Single dose of BW-40202 | Active comparator | Drug: BW-40202 injectionIf 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 |
| Arm 6: Placebo | Placebo comparator | Other: Sodium ChlorideThere will be 2 participants within each cohort be randomized to receive placebo. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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 (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BW-40202 injectionBW-40202 is a conjugate drug, dosage form is solution for injection and route of administration is subcutaneous injection | Drug | Arm1: Single dose of BW-40202, Arm2: Single dose of BW-40202, Arm3: Single dose of BW-40202, Arm4: Single dose of BW-40202, Arm5: Single dose of BW-40202 |
| Sodium ChloridePlacebo (sodium chloride injection) will be administered as Subcutaneous injection | Other | Arm 6: Placebo |
Primary outcome
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.
Time frame: From first participant enrolled until Day 169 post-dose of last participant
Incidence of TEAEs (%) = (number of subjects with TEAEs/Total number of subjects) *100 Incidence of SAEs (%) = (number of subjects with SAEs/total number of subjects)*100
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.
Time frame: From first participant enrolled until Day 169 post-dose of last participant
Adverse events (AEs) were coded using the latest MedDRA version available at the time of study commencement. All AEs were collected after drug administration and were considered TEAEs to be included in the summaries. Summary tables included the number of subjects (%) experiencing an event and the number of events. Subjects who experienced multiple AEs were only counted once in each category (system organ class [SOC] and preferred term [PT]), but all events were included in the event frequencies (categorical descriptive analysis). The TEAE summaries included: * Overall summary of TEAEs. * TEAE summary by SOC and PT. * TEAE summary of serious events by SOC and PT. * TEAE summary of study-drug related events by SOC and PT. TEAE summary by SOC, PT, and Toxicity Grading. * TEAE summary by SOC, PT, and relationship to study drug. * TEAE summary of events leading to study discontinuation by SOC and PT. * TEAE summary of Injection Site reactions.
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.
Time frame: From first participant enrolled until Day 169 post-dose of last participant
Adverse events are graded based on severity: Mild (Grade 1): No significant impact on daily activities Moderate (Grade 2): Some interference with daily activities Severe (Grade 3): Significant impact on function Life-threatening (Grade 4): Immediate risk of death Fatal (Grade 5): Resulted in death. Severity distribution = (number of subjects with grade X TEAE/total TEAE cases) *100
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.
Time frame: From first participant enrolled until Day 169 post-dose of last participant
The safety laboratory data will be summarized by visit and by treatment group, along with changes from baseline. The values that are below the lower limit or above the upper limit of the reference range will be flagged for safety. Those values or changes in values that are identified as being clinically significant will be flagged.
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.
Time frame: From first participant enrolled until Day 169 post-dose of last participant
The safety laboratory data will be summarized by visit and by treatment group, along with changes from baseline. The values that are below the lower limit or above the upper limit of the reference range will be flagged for safety. Those values or changes in values that are identified as being clinically significant will be flagged.
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.
Time frame: From first participant enrolled until Day 169 post-dose of last participant
The safety laboratory data will be summarized by visit and by treatment group, along with changes from baseline. The values that are below the lower limit or above the upper limit of the reference range will be flagged for safety. Those values or changes in values that are identified as being clinically significant will be flagged.
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.
Time frame: From first participant enrolled until Day 169 post-dose of last participant
The safety laboratory data will be summarized by visit and by treatment group, along with changes from baseline. The values that are below the lower limit or above the upper limit of the reference range will be flagged for safety. Those values or changes in values that are identified as being clinically significant will be flagged.
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.
Time frame: From first participant enrolled until Day 169 post-dose of last participant
Abnormal physical examination findings will be listed.
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.
Time frame: From first participant enrolled until Day 169 post-dose of last participant
Abnormal physical examination findings will be listed.
Vital signs (temperature,degrees Celsius) changes from Baseline values to Day 169 post dose will be summarized in the table by treatment group.
Time frame: From first participant enrolled until Day 169 post-dose of last participant
Abnormal physical examination findings will be listed.
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.
Time frame: From first participant enrolled until Day 169 post-dose of last participant
12-lead ECGs will be summarized by visit and by treatment group, along with the changes from baseline.The summary of overall interpretation findings table presented counts and percentages for the reported results at Baseline and Day 169/time point. Result categories were ordered as 'Normal', 'Abnormal Not Clinically Significant (NCS)' and 'Abnormal Clinically Significant (CS)' (categorical descriptive analysis).
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..
Time frame: From first participant enrolled until Day 169 post-dose of last participant
Abnormal physical examination findings will be listed.
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.
Time frame: From first participant enrolled until Day 169 post-dose of last participant
Abnormal physical examination findings will be listed.
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.
Time frame: From first participant enrolled until Day 169 post-dose of last participant
The safety laboratory data will be summarized by visit and by treatment group, along with changes from baseline. The values that are below the lower limit or above the upper limit of the reference range will be flagged for safety. Those values or changes in values that are identified as being clinically significant will be flagged.
Coagulation results (International normalized ratio) at each time point, including changes from baseline to Day 169 post dose will be summarized by treatment group.
Time frame: From first participant enrolled until Day 169 post-dose of last participant
The safety laboratory data will be summarized by visit and by treatment group, along with changes from baseline. The values that are below the lower limit or above the upper limit of the reference range will be flagged for safety. Those values or changes in values that are identified as being clinically significant will be flagged.
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.
Time frame: From first participant enrolled until Day 169 post-dose of last participant
The safety laboratory data will be summarized by visit and by treatment group, along with changes from baseline. The values that are below the lower limit or above the upper limit of the reference range will be flagged for safety. Those values or changes in values that are identified as being clinically significant will be flagged.
6 secondary outcomes
maximum plasma concentration data (Cmax, ng/mL) of BW-40202 will be collected for all cohorts at the scheduled PK sampling timepoints.
Time frame: From first patient enrolled until Day 8 post-dose of last patient.
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.
Time frame: From first patient enrolled until Day 8 post-dose of last patient.
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.
Time frame: From first patient enrolled until Day 8 post-dose of last patient.
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)
Time frame: From first patient enrolled until Day 8 post-dose of last patient
Calculate the Urine output (Aet, mg), Aet (total amount of drug excreted in urine during each time interval)
Time frame: From first participant being enrolled until 24 hours post-dose of last enrolled participant
Calculate the Urine output (Clr, L/h), the renal clearance measures the efficiency of drug elimination by the kidneys.
Time frame: From first participant being enrolled until 24 hours post-dose of last enrolled participant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhuo Chang, MD. Ph.D study director
Shanghai Argo Biopharmaceutical Co., Ltd.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BW-40202 injection and Sodium Chloride in people with Healthy Volunteers Only, run by Shanghai Argo Biopharmaceutical Co., Ltd. at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Di Hu, M.sc (+86 15601969786, di.hu@argobiopharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: From first participant enrolled until Day 169 post-dose of last participant). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2025.