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To evaluate the safety and tolerability of BAT2022 in healthy subjects.
This is a single-center, randomized, double-blind, placebo-controlled, dose-escalation clinical study to evaluate the pharmacokinetics, safety, tolerability, immunogenicity and pharmacodynamics of BAT2022 for Injection in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A1/100mg | Experimental | Drug:BAT2022 for Intravenous fluids 100mg |
|
| A2/300mg | Experimental | Drug:BAT2022 for Intravenous fluids 300mg |
|
| A3/1000mg | Experimental | Drug:BAT2022 for Intravenous fluids 1000mg |
|
| A4/1500mg | Experimental | Drug:BAT2022 for Intravenous fluids 1500mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAT2022 | Drug | Eight healthy subjects are planned to be enrolled in each group, 6 on the investigational product and 2 on placebo. Subjects will be randomized (3:1) to receive a single intravenous injection of BAT2022 for Injection or 5% glucose injection. Sentinel dosing will be performed for subjects in each group.Two subjects in each group who have received the first dose will be randomized (1:1) to either the test group or placebo group. After observation for 24 h and the drug is safe and well tolerated, the remaining subjects in this group will be randomized (5:1) to either the test group or placebo group. |
| Measure | Description | Time Frame |
|---|---|---|
| Dose limiting toxicity (DLT) | Grade ≥3 AEs in this criteria are defined as dose-limiting toxicity (DLT). | DLT observation period is 7 days postdose. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerated dose (MTD) | it is determined that ≥ 50% of subjects have experienced a DLT as defined in this protocol | DLT observation period is 7 days postdose. |
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: Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Weiyong Li | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Union Hospital Tong Ji Medical College University of Science and Technology | Wuhan | Hubei | 430030 | China |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000723330 | BAT2022 |
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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Double-Blind
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|
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |