NCT05058105View on ClinicalTrials.gov

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

PHASE1CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

October 8, 2020

Primary Completion Date

February 24, 2021

Study Completion Date

February 24, 2021

Conditions
Healthy
Interventions
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"

Trial Locations (1)

Unknown

Huashan Hospital affiliated to Fudan University, Shanghai

All Listed Sponsors
lead

Qilu Pharmaceutical Co., Ltd.

INDUSTRY

NCT05058105 - Safety, Tolerability, Pharmacokinetics of Intravenous FL058 and Meropenem in Healthy Subjects(SAD/MAD) | Biotech Hunter | Biotech Hunter