Single-dose PK Study of Benapenem In Healthy Subjects
Condition: Healthy Subject
Study type: Interventional
Phase: Phase 1

Summary: 
      To design 11 dose groups within 62.5 mg ~ 4000 mg for single-dose tolerability study. A
      single-center, randomized, blinded, placebo-controlled, dose escalation trial design is
      adopted. 8 subjects each in 62.5 mg, 125 mg, 3000 mg and 4000 mg dose groups, 10 subjects
      each in other groups, including 2 placebo-controlled subjects. To be carried out from
      low-dose group to high-dose group. The next dose group can be studied only when the
      observation of the previous dose group is completed and it is confirmed that the drug is
      safely tolerated. The test should be stopped in case of serious adverse reactions, or when
      more subjects experience adverse reactions and have reached termination criteria of the
      trial, even if the maximum dose has not been reached.

      Infusion time is planned to be 30 min in 62.5 mg, 125 mg and 250 mg ; two infusion time, 30
      min and 60 min, in 500 mg, 1000 mg and 2000 mg groups. If subjects can tolerate 60-min
      infusion, the same dose group at infusion time of 30 min is added. The 3000 mg and 4000 mg
      dose groups only receive 60-min infusion for investigation of tolerability.
    

Detailed description: 
      It is planned to design 11 dose groups within 62.5 mg ~ 4000 mg for single-dose tolerability
      study. A single-center, randomized, blinded, placebo-controlled, dose escalation trial design
      is adopted. There are 8 subjects each in 62.5 mg, 125 mg, 3000 mg and 4000 mg dose groups,
      and 10 subjects each in other groups. Each group consists of half males and half females,
      including 2 placebo-controlled subjects (1 male and 1 female). The trial is carried out from
      low-dose group to high-dose group. Each subject only receives one dose of test drug, which is
      dissolved in 100 mL of 0.9% NS, intravenous drip. During the trial, the adverse events of
      subjects should be closely followed. The next dose group can be studied only when the
      observation of the previous dose group is completed and it is confirmed that the drug is
      safely tolerated. The test should be stopped in case of serious adverse reactions, or when
      more subjects experience adverse reactions and have reached termination criteria of the
      trial, even if the maximum dose has not been reached.

      In order to investigate possible effect of infusion rate on the tolerability and to ensure
      the safety of subjects, the infusion time is planned to be 30 min in 62.5 mg, 125 mg and 250
      mg low-dose groups; two infusion time, 30 min and 60 min, in 500 mg, 1000 mg and 2000 mg
      groups. Under the circumstance that subjects can tolerate 60-min infusion, the same dose
      group at infusion time of 30 min is added to investigate the possible effect of infusion rate
      on the tolerability. The 3000 mg and 4000 mg dose groups only receive 60-min infusion for
      investigation of tolerability.
    

Intervention name(s): Benapenem; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 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; Placebo
Other intervention name(s): 5081
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 11 dose groups within 62.5 mg ~ 4000 mg for single-dose tolerability study to carried out from low-dose group to high-dose group
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Healthy Subject; PK Study; Tolerability; Safety Evaluation