NCT03588156View on ClinicalTrials.gov

Single-dose PK Study of Benapenem In Healthy Subjects

PHASE1CompletedINTERVENTIONAL
Enrollment

98

Participants

Timeline

Start Date

March 11, 2015

Primary Completion Date

September 17, 2015

Study Completion Date

September 17, 2015

Conditions
Healthy Subject
Interventions
DRUG

Benapenem

Dose-escalation For 11 level dose groups A1 \~ A11(each 62.5mg/kg, 125mg/kg, 250mg/kg, 500mg/kg, 1000mg/kg 60min infusion, 1000mg/kg 30min infusion, 2000mg/kg 60 min infusion, 2000mg/kg 30min infusion, 3000mg/kg, 4000mg/kg), 10 subjects (8 for the study drug and 2 for placebo) are randomized to each dose group

DRUG

Placebo

Placebo

All Listed Sponsors
lead

Sihuan Pharmaceutical Holdings Group Ltd.

INDUSTRY

NCT03588156 - Single-dose PK Study of Benapenem In Healthy Subjects | Biotech Hunter | Biotech Hunter