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To evaluate the safety,tolerability and pharmacokinetics of single intravenous doses of FL058 in healthy Chinese subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FL058 | Experimental | a single ascending dose (SAD) of intravenous (IV) FL058(50mg~2000mg) |
|
| Placebo | Placebo Comparator | FL058 Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FL058 | Drug | 50mg、250mg、500mg、1000mg、1500mg、2000mg |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with adverse events [Safety and Tolerability] | Day 1 to Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| FL058 -Cmax | To evaluate the PK of single intravenous doses of FL058 in healthy adult human subjects. | Up to 48 hours post-dose |
| FL058 -AUC | To evaluate the PK of single intravenous doses of FL058 in healthy adult human subjects. |
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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 |
|
| Up to 48 hours post-dose |
| FL058 -t1/2 | To evaluate the PK of single intravenous doses of FL058 in healthy adult human subjects. | Up to 48 hours post-dose |