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This is a randomized, double-blind, single-dose, parallel two-arm study to compare the pharmacokinetics, safety, and immunogenicity of BAT1706 Injection from different manufacturing batches (by new process and old process) in healthy male subjects.
A total of 38 subjects are planned to be enrolled and randomized in a 1: 1 ratio to receive a single intravenous drip of BAT1706 Injection (by old process) or BAT1706 Injection (by new process) at 1 mg/kg body weight.
A 7-day screening period will be set up for this study. Subjects will be admitted to the hospital 1 day pre-dose (Day -1) and discharged after completing relevant observations and assessments 24 h post-dose. After discharge, subjects should return to the hospital for 12 follow-up visits according to the requirements of this study, on Days 3, 4, 5, 8, 11, 15, 22, 29, 36, 43, 57 and 71 post-dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BAT1706(New Process) | Experimental | Drug: BAT1706 1 mg/kg, the corresponding volume of bulk solution should be drawn according to the actual body weight of the subject, diluted to 100 mL with 0.9% sodium chloride solution, and administered by intravenous drip |
|
| BAT1706(Old Process) | Active Comparator | Drug: BAT1706 1 mg/kg, the corresponding volume of bulk solution should be drawn according to the actual body weight of the subject, diluted to 100 mL with 0.9% sodium chloride solution, and administered by intravenous drip |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAT1706 Injection | Drug | 1 vial/carton, 400 mg/16 mL/vial |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-inf | Area under the plasma concentration-time curve from zero to infinity, AUC0-∞ = AUC0-t + Ct/λz | Day1, 2, 3, 4, 5, 8,15, 22, 29, 36, 43, 57, 71 |
| AUC0-t | Area under the blood concentration-time curve from time 0 to the last time point at which the concentration can be measured | Day1, 2, 3, 4, 5, 8,15, 22, 29, 36, 43, 57, 71 |
| Cmax | Maximum blood concentration | Day1, 2, 3, 4, 5, 8,15, 22, 29, 36, 43, 57, 71 |
| Tmax | Observed time to peak concentration | Day1, 2, 3, 4, 5, 8,15, 22, 29, 36, 43, 57, 71 |
| t1/2 | Elimination half-life t1/2 = 0.693/λz | Day1, 2, 3, 4, 5, 8,15, 22, 29, 36, 43, 57, 71 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | AE and SAE | Day1, 2, 3, 4, 5, 8,15, 22, 29, 36, 43, 57, 71 |
| Immunogenicity | Anti-drug antibody (ADA) positivity, ADA titer and neutralizing antibody (NAb) positivity for ADA. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenting Li | Contact | 15812648239 | wtli1@bio-thera.com | |
| Zhaohe Wang, Ph.D | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Wei Hu, Ph.D | The Second Hospital of Anhui Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Anhui Medical University | Hefei | Anhui | China |
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| Day1, 2, 3, 4, 5, 8,15, 22, 29, 36, 43, 57, 71 |