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A Phase 1 Study of Single-Dose BW-50218 in Healthy Chinese Participants
A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of A Single Dose of BW-50218 in Healthy Chinese Participants
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BW-50218 Dose1 | Experimental | Single dose of BW-50218 injection (Dose 1) |
|
| BW-50218 Dose 2 | Experimental | Single dose of BW-50218 injection (Dose 2) |
|
| BW-50218 Dose 3 | Experimental | Single dose of BW-50218 injection (Dose 3) |
|
| Saline Placebo | Placebo Comparator | Single dose of Saline Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BW-50218 Injection | Drug | Solution for injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAES) | Evaluation of the number of participants with treatment-emergent adverse events and serious adverse events. The severity of AEs will be assessed and categorized according to the "Guidance for industry: Toxicity Grading Scale for Healthy Adultand Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials" (FDA, 2007). | From baseline up to Day 360 (End of Study) |
| Hematology results (Platelets, 10^9/L) at each time point, including changes from baseline to Day 360 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 ofthe reference range will be flagged for safety. Those values or changes in values that are identified as being clinically significant will be flagged. | From baseline up to Day 360 (End of Study) |
| Hematology results (concentration of Hemoglobin, g/L) at each time point, including changes from baseline to Day 360 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 ofthe reference range will be flagged for safety. Those values or changes in values that are identified as being clinically significant will be flagged. | From baseline up to Day 360 (End of Study) |
| Chemistry results (Albumin, g/L) at each time point from baseline to Day 360 will be summarized bytreatment 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 ofthe reference range will be flagged for safety. Those values or changes in values that are identified as being clinically significant will be flagged. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | Evaluation of the maximum plasma concentration of BW-50218. | From pre-dose up to Day 8 |
| Time to Maximum Plasma Concentration (Tmax) | Evaluation of the time to reach maximum plasma concentration. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yuqiong Li | Shanghai Argo Biopharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Argo Investigative Site | Shanghai | China |
A decision regarding sharing of de-identified IPD will be made by the Sponsor after study completion and will consider scientific merit, participant privacy, and regulatory requirements.
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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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| Saline (0.9% NaCl) | Drug | Solution for injection |
|
| From baseline up to Day 360 (End of Study) |
| Chemistry results (Alkaline Phosphatase, U/L; Alanine Aminotransferase, U/L; Aspartate Aminotransferase, U/L) at each time point from baseline to Day 360 will be summarized bytreatment 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 ofthe reference range will be flagged for safety. Those values or changes in values that are identified as being clinically significant will be flagged. | From baseline up to Day 360 (End of Study) |
| Chemistry results (Direct Bilirubin, umol/L) at each time point from baseline to Day 360 will be summarized bytreatment 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 ofthe reference range will be flagged for safety. Those values or changes in values that are identified as being clinically significant will be flagged. | From baseline up to Day 360 (End of Study) |
| Urinalysis results (Epithelial cells, crystals, casts, bilirubin) at each time point,including change from baseline to Day 360 post dose will be summarized in thetable 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 ofthe reference range will be flagged for safety. Those values or changes in values that are identified as being clinically significant will be fagged. | From baseline up to Day 360 (End of Study) |
| Vital signs (Blood pressures, millimeters of mercury) changes from Baselinevalues to Day 360 post dose will be summarized in the table by treatment group | Abnormal physical examination findings will be listed. | From baseline up to Day 360 (End of Study) |
| Vital signs (Heart rate, beats per minute) changes from Baseline values to Day 360 post dose will be summarized in the table by treatment group. | Abnormal physical examination findings will be listed. | From baseline up to Day 360 (End of Study) |
| Vital signs (Respiratory rate, times per minute) changes from Baseline values to Day 360 post dose will be summarized in the table by treatment group. | Abnormal physical examination findings will be listed. | From baseline up to Day 360 (End of Study) |
| Vital signs (Temperature,degrees Celsius) changes from Baseline values to Day 360 post dose will be summarized in the table by treatment group. | Abnormal physical examination findings will be listed. | From baseline up to Day 360 (End of Study) |
| Changes in ECG (PR Interval, msec; QRs Duration, msec;QT interval, msec; RR interval, msec; QTcF Interval, msec; ) from Baseline to Day 360 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 360/time point. Result categories were ordered as "Normal", "Abnormal Not Clinically Significant (NCS)" and "Abnormal Clinically Significant (CS)"(categorical descriptive analysis). | From baseline up to Day 360 (End of Study) |
| Changes in ECG (Mean heart rate, bpm ) from Baseline to Day 360 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 360/time point. Result categories were ordered as "Normal", "Abnormal Not Clinically Significant (NCS)" and "Abnormal Clinically Significant (CS)"(categorical descriptive analysis). | From baseline up to Day 360 (End of Study) |
| Change from Baseline in Physical Examination Findings | Assessment of clinically significant changes in physical examination findings | From baseline up to Day 360 (End of Study) |
| Hematology results (Red blood cell count, 10^12/L) at each time point, including changes from baseline to Day 360 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 ofthe reference range will be flagged for safety. Those values or changes in values that are identified as being clinically significant will be flagged. | From baseline up to Day 360 (End of Study) |
| From pre-dose up to Day 8 |
| Area Under the Plasma Concentration-Time Curve (AUC) | Evaluation of AUc from time zero to 24 hours (AUC0-24), to 48 hours (AUC0-48), and to infinity (AUC0-inf) | From pre-dose up to Day 8 |
| Terminal Elimination Half-Life (t1/2) | Evaluation of the elimination half-life of BW-50218 | From pre-dose up to Day 8 |
| Urine Pharmacokinetic Parameters (Renal Clearance, CLr) | Renal clearance calculated as CLr = CAe/Plasma AUC 0-24. Ae=cumulative amount excreted in urine (mg). AUC 0-24 = Area under the plasma concentration - time curve from 0 to 24 hours(e.g.mg*h/mL) | From pre-dose up to 24 hours post-dose |
| D017670 |
| Sodium Compounds |