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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm1: Single dose of BW-40202 | Active Comparator | 6 out of 8 participants randomized to cohort 1 will receive BW-40202 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BW-40202 injection | Drug | BW-40202 is a conjugate drug, dosage form is solution for injection and route of administration is subcutaneous injection |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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:
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| maximum plasma concentration data (Cmax, ng/mL) of BW-40202 will be collected for all cohorts at the scheduled PK sampling timepoints. |
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Key inclusion criteria:
Key exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Di Hu, M.sc | Contact | +86 15601969786 | di.hu@argobiopharma.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhuo Chang, MD. Ph.D | Shanghai Argo Biopharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Q-Pharm Pty Ltd. | Recruiting | Brisbane | Queensland | 4006 | Australia | |
| Nucleus Network Pty Ltd |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Arm 6: Placebo | Placebo Comparator | There will be 2 participants within each cohort be randomized to receive placebo. |
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| Sodium Chloride | Other | Placebo (sodium chloride injection) will be administered as Subcutaneous injection |
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| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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). | 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. | 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. | 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. | 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. | 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. | From first participant enrolled until Day 169 post-dose of last participant |
| 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. |
| 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. | 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) |
| 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. | 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) | From first participant being enrolled until 24 hours post-dose of last enrolled participant |
| Not yet recruiting |
| Melbourne |
| Victoria |
| 3004 |
| Australia |
| D017670 |
| Sodium Compounds |