Healthy Participants Study
Conditions
Brief summary
A Phase 1 Study of Single-Dose BW-50218 in Healthy Chinese Participants
Detailed description
A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of A Single Dose of BW-50218 in Healthy Chinese Participants
Interventions
Solution for injection
DRUGSaline (0.9% NaCl)
Solution for injection
Sponsors
Shanghai Argo Biopharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Capable of providing written informed consent and complying with all study procedures for the duration of the study. * Body weight \> 50 kg for males and \> 45 kg for females; body mass index (BMI) within a range considered appropriate for study participation by the investigator. * Female participants must be non-pregnant, non-lactating, and either of non-childbearing potential or using highly effective contraception. * Male participants with partners of childbearing potential must agree to use effective contraception.
Exclusion criteria
* Any clinically significant chronic medical condition or clinically significant abnormality in physical examination that, in the opinion of the Investigator, makes the participant unsuitable for participation in the study. * Recent hospitalization or a significant acute medical event. * History of cancer or any long-term medical condition that the study doctor considers clinically relevant. * Clinical laboratory findings outside of range which are deemed clinically significant by the investigator at screening or Day -1. * Positive test for hepatitis B, hepatitis C, or HIV.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAES) | From baseline up to Day 360 (End of Study) | 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). |
| 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. | From baseline up to Day 360 (End of Study) | 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. |
| 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. | From baseline up to Day 360 (End of Study) | 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. |
| Chemistry results (Albumin, g/L) at each time point from baseline to Day 360 will be summarized bytreatment group. | From baseline up to Day 360 (End of Study) | 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. |
| 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. | From baseline up to Day 360 (End of Study) | 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. |
| Chemistry results (Direct Bilirubin, umol/L) at each time point from baseline to Day 360 will be summarized bytreatment group. | From baseline up to Day 360 (End of Study) | 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. |
| 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. | From baseline up to Day 360 (End of Study) | 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. |
| Vital signs (Blood pressures, millimeters of mercury) changes from Baselinevalues to Day 360 post dose will be summarized in the table by treatment group | From baseline up to Day 360 (End of Study) | Abnormal physical examination findings will be listed. |
| 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. | From baseline up to Day 360 (End of Study) | Abnormal physical examination findings will be listed. |
| 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. | From baseline up to Day 360 (End of Study) | Abnormal physical examination findings will be listed. |
| Vital signs (Temperature,degrees Celsius) changes from Baseline values to Day 360 post dose will be summarized in the table by treatment group. | From baseline up to Day 360 (End of Study) | Abnormal physical examination findings will be listed. |
| 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. | From baseline up to Day 360 (End of Study) | 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). |
| Changes in ECG (Mean heart rate, bpm ) from Baseline to Day 360 post-dose will be summarized. | From baseline up to Day 360 (End of Study) | 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). |
| Change from Baseline in Physical Examination Findings | From baseline up to Day 360 (End of Study) | Assessment of clinically significant changes in physical examination findings |
| 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. | From baseline up to Day 360 (End of Study) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | From pre-dose up to Day 8 | Evaluation of the maximum plasma concentration of BW-50218. |
| Time to Maximum Plasma Concentration (Tmax) | From pre-dose up to Day 8 | Evaluation of the time to reach maximum plasma concentration. |
| Area Under the Plasma Concentration-Time Curve (AUC) | From pre-dose up to Day 8 | Evaluation of AUc from time zero to 24 hours (AUC0-24), to 48 hours (AUC0-48), and to infinity (AUC0-inf) |
| Terminal Elimination Half-Life (t1/2) | From pre-dose up to Day 8 | Evaluation of the elimination half-life of BW-50218 |
| Urine Pharmacokinetic Parameters (Renal Clearance, CLr) | From pre-dose up to 24 hours post-dose | 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) |
Countries
China
Contacts
STUDY_DIRECTORYuqiong Li
Shanghai Argo Biopharmaceutical Co., Ltd.
Outcome results
None listed