NCT03570970

Multiple-dose Tolerability and Pharmacokinetic Studies of Benapenem inClinical Healthy Subjects

Multiple-dose Tolerability and Pharmacokinetic Studies of Benapenem for Injection in Phase Ib Clinical Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Sihuan Pharmaceutical Holdings Group Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

To observe the pharmacokinetic profiles of benapenem and its major metabolites in healthy volunteers after continuous multiple-dose benapenem, providing evidence for phase Ⅱ clinical study.

Detailed description

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. Three doses, 250 mg, 500 mg, and 1000 mg are proposed for multiple-dose tolerability and pharmacokinetic studies. The subjects are divided into two groups, 12 subjects in each group, half males and half females. 250 mg group is performed firstly. After completion of observation and confirming that the drug can be safely tolerated, study on 500 mg group is then performed. After completion of observation and confirming that the drug can be safely tolerated, study on 1000 mg group is then performed. Each subject only receives one dose, intravenous drip, once daily, for 7 consecutive days. During the trial, close attention is paid to the tolerability of subjects, and blood samples 4 mL is collected from cubital vein respectively before dosing, 0.25 h, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 3 h, 5h, 8 h, 12 h, and 24 h after dosing on Day 1 (0 h); before dosing (0 h), 0.25 h, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 3 h, 5 h, 8 h, 12 h, 24 h, 36 h, and 48 h after dosing on Day 7 for pharmacokinetic study. Blood samples are collected before dosing on Day 4, 5 and 6 to determine the trough concentration for observing the pharmacokinetic profiles of benapenem and its major metabolites in the body after continuous dosing. 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

Conditions

• Healthy Subject

Interventions

Type	Name	Description
DRUG	Banapenem	Banapenem to be used anti-infection

Timeline

• Start date: 2016-03-14
• Primary completion: 2016-06-02
• Completion: 2016-06-02
• First posted: 2018-06-27
• Last updated: 2018-06-27