NCT05058105

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

A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single- and Multiple Ascending-dose Study of the Safety, Tolerability, and Pharmacokinetics of Intravenous FL058 and Meropenem Alone and in Combination in Healthy Chinese Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Qilu Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	FL058 500mg and Meropenem 1000mg（ IV 120min）	D1 qd; D2\~ D8 q8h; D9 qd
DRUG	FL058 Placebo and Meropenem 1000mg（ IV 120min）	D1 qd; D2\~ D8 q8h; D9 qd
DRUG	FL058 1000mg（ IV 120min）	D1 qd;
DRUG	FL058 Placebo （ IV 120min）	D1 qd;
DRUG	Meropenem 1000 mg （ IV 120min）	D4 qd;
DRUG	Meropenem Placebo （ IV 120min）	D4 qd;
DRUG	FL058 1000mg and Meropenem 1000mg （ IV 120min）	D7 qd; D8\~ D14 q8h; D15 qd;
DRUG	FL058 Placebo and Meropenem 1000mg （ IV 120min）	D7 qd; D8\~ D14 q8h; D15 qd;
DRUG	FL058 1000mg and Meropenem 2000mg （ IV 120min）	D1 qd; D2\~ D8 q8h; D9 qd
DRUG	FL058 Placebo and Meropenem 2000m（ IV 120min）	D1 qd; D2\~ D8 q8h; D9 qd
DRUG	FL058 1000mg and Meropenem 2000mg （ IV 180min）	D1 qd; D2\~ D8 q8h; D9 qd
DRUG	FL058 Placebo and Meropenem 2000m（ IV 180min）	D1 qd; D2\~ D8 q8h; D9 qd
DRUG	FL058 2000mg and Meropenem 2000mg（ IV 180min）	D1 qd; D2\~ D8 q8h; D9 qd
DRUG	FL058 Placebo and Meropenem 2000mg（ IV 180min）	D1 qd; D2\~ D8 q8h; D9 qd

Timeline

• Start date: 2020-10-08
• Primary completion: 2021-02-24
• Completion: 2021-02-24
• First posted: 2021-09-27
• Last updated: 2021-09-27

Locations

1 site across 1 country: China