Benapenem PK Phase Ib Multiple-dose Study
Condition: Health, Subjective
Study type: Interventional
Phase: Phase 1

Summary: 
      A single-center, randomized, open-label, three-period and three-crossover trial design is
      adopted in the single-dose pharmacokinetic study. 12adult volunteers, are assigned to 3
      groups, B1（250mg), B2 (500mg), and B3 (1000mg). Each group of subjects receive single-dose
      test drug at different dosages in each period.

      The tolerability and pharmacokinetic studies are performed simultaneously. Two doses, 250 mg
      and 500 mg, are proposed for multiple-dose tolerability and pharmacokinetic studies. 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. Each subject receives only one dose,
      intravenous drip, once daily, for 7 consecutive days
    

Detailed description: 
      A single-center, randomized, open-label, three-period and three-crossover trial design is
      adopted in the single-dose pharmacokinetic study. 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.

      A single-center, randomized, open- label, and dose escalation trial design is used in the
      multiple-dose tolerability and pharmacokinetic studies. The tolerability and pharmacokinetic
      studies are performed simultaneously. Two doses, 250 mg and 500 mg, are proposed for
      multiple-dose tolerability and pharmacokinetic studies. 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. Each subject receives only one dose,
      intravenous drip, once daily, for 7 consecutive days
    

Intervention name(s): Banapenem
Intervention type(s): Drug
Intervention description(s): 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
Other intervention name(s): 5081
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: A single-center, randomized, open-label, three-period and three-crossover trial design is adopted in the single-dose pharmacokinetic study; A single-center, randomized, open- label, and dose escalation trial design is used in the multiple-dose tolerability and pharmacokinetic studies
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: single dose; multiple dose; Pharmacokinetic; Tolerability; Healthy Subject; Benapenem