Safety, Tolerability, Pharmacokinetics of Intravenous FL058 and Meropenem in Healthy Subjects(SAD/MAD)

Phase 1 Completed 40 enrolled Qilu Pharmaceutical Co., Ltd.

RandomizedParallel-groupDouble-blindTreatment

Summary

Phase 1 Study of the Safety, Tolerability, and Pharmacokinetics of FL058 and Meropenem Alone and in Combination following Single and Multiple Doses in Healthy Adult Subjects.

Timeline

Start: 2020-10-08
Primary completion: 2021-02-24
Completion: 2021-02-24

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	FL058	Small molecule	500 mg	Intravenous
Subject	FL058	Small molecule	1000 mg	Intravenous
Subject	FL058	Small molecule	2000 mg	Intravenous
Subject	Meropenem	Small molecule	1000 mg	Intravenous
Subject	Meropenem	Small molecule	2000 mg	Intravenous

Indications

No indication recorded.