Benapenem PK Phase Ib Multiple-dose Study

PHASE1CompletedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

December 14, 2015

Primary Completion Date

January 13, 2016

Study Completion Date

January 13, 2016

Conditions
Health, Subjective
Interventions
DRUG

Banapenem

Twelve healthy adult volunteers, half male and female, are enrolled and randomly assigned to three groups, B1, B2, and B3. The subjects in three groups receive three doses, 250 mg, 500 mg and 1000 mg. Each group of subjects receive single-dose test drug at different dosages in each period. The subjects are divided into two groups, C1 and C2, 12 subjects in each group, half males and half females. 250 mg group is performed first. After completion of observation and confirming that the drug can be safely tolerated, study on 500 mg group is then performed

All Listed Sponsors
lead

Sihuan Pharmaceutical Holdings Group Ltd.

INDUSTRY

NCT03578588 - Benapenem PK Phase Ib Multiple-dose Study | Biotech Hunter | Biotech Hunter