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To evaluate the safety,tolerability and pharmacokinetics of single-multiple intravenous doses of FL058 in healthy Chinese subjects.
This study is divided into two parts: A and B.Part A discusses the safety and tolerability of IV FL058 single ascending dose (SAD) in two cohorts. Part B discusses the safety and tolerability of intravenous injection of FL058 in multiple dose (MAD) in three cohorts.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A:FL058 | Experimental | a single ascending dose (SAD) of intravenous (IV) FL058(2500mg~3000mg) |
|
| Part A:Placebo | Placebo Comparator | FL058 Placebo |
|
| Part B:FL058 | Experimental | a multiple ascending dose (MAD) of intravenous (IV) FL058(500mg~2000mg) |
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| Part B:Placebo | Placebo Comparator | FL058 Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FL058 | Drug | 2500mg、3000mg |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Part A:Number of patients with adverse events [Safety and Tolerability] | Day 1 to Day 7 | |
| Part B:Number of patients with adverse events [Safety and Tolerability] | Day 1 to Day 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital affiliated to Fudan University | Shanghai | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38054726 | Derived | Huang Z, Yang X, Jin Y, Yu J, Cao G, Wang J, Hu Y, Dai J, Wu J, Wei Q, Tian Y, Yu S, Zhu X, Mao X, Liu W, Liang H, Zheng S, Ju Y, Wang Z, Zhang J, Wu X. First-in-human study to evaluate the safety, tolerability, and population pharmacokinetic/pharmacodynamic target attainment analysis of FL058 alone and in combination with meropenem in healthy subjects. Antimicrob Agents Chemother. 2024 Jan 10;68(1):e0133023. doi: 10.1128/aac.01330-23. Epub 2023 Dec 6. |
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| Drug |
empty bottle |
|
| FL058 | Drug | 500mg、1000mg、2000mg |
|
| Placebo | Drug | empty bottle |
|