Multiple-dose Tolerability and Pharmacokinetic Studies of Benapenem in Clinical Healthy Subjects

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

Study Overview

• Status: Unknown
• Conditions: Multiple-dose Tolerability and Pharmacokinetic Studies of Benapenem in Clinical Healthy Subjects
• Intervention / Treatment: Drug: Banapenem; Drug: sodium chloride

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Yuan Lv, Doctor; Phone Number: 18813015605; Email: LYU18813015605@126.com

Study Locations

• China
  • Beijing
    • Peking, Beijing, China
      • Recruiting
      • Peking University first hospital
      • Contact: Yuan Lv, Doctor; Phone Number: 18813015605; Email: LYU18813015605@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 1、 Male or female healthy subjects, aged 18~45(including 18 and 45 years); 2、Body weight ≥ 50 kg and body mass index 19.0~24.0 kg/m2; 3、Prior to the test, physical examination, blood routine, urine routine, liver and kidney functions, and related examinations normal, or mild abnormalities in indicators while without clinical significance as indicated by the investigator ; 4、Normal or mild abnormalities without clinical significance in the standard 12-lead ECG; 5、 Signing informed consent form.

Exclusion Criteria:

• 1、Having a serious systemic disease, infectious disease or mental disorder; 2、Regular smoking, alcohol abuse, and drug abuse ; 3、Use of drugs known damage to an organ within three months; 4、History of specific allergies, or history of drug allergy, especially those allergic to lactams and excipients of test drug; 5、Febrile illnesses within three days before the screening; 6、Patients with mental illness or psychotic disorder in the past; 7、Past mental and nervous system diseases (epilepsy, stroke, cerebrovascular disorder, etc.), gastrointestinal disorder (such as stomach ulcers, gastritis, etc.) or disorder of other systems (such as cardiovascular, respiratory, hematological, or endocrine system, etc.) diseases or medical history; 8、Habitually taking any medication, including traditional Chinese medicine; 9、Having taken any medication that may affect test results within two weeks before the screening, such as antibiotics, NSAIDs, aluminum- or magnesium-containing antacids, diuretics, anticoagulants, central nervous system depressants, and any drug that may affect the drug absorption; 10、Having participated in other investigational drug trial in the preceding three months; 11、Blood donation for 360 ml or more within three months before the screening; 12、Heart rate < 50 bpm or > 100 bpm; 13、Systolic blood pressure<90mmHg or ≥ 140mmHg, diastolic blood pressure ≥ 90 mmHg or <60mmHg ; 14、Women who are pregnant or breastfeeding, or who may be pregnant without adopting acceptable contraception, or who have a positive result in serum pregnancy test; 15、Women who are planning to become pregnant within 6 months, or male subjects who are planning to make his spouse pregnant within 6 months; 16、HBsAg, HCV antibody, HIV antibody, and Treponema pallidum antibody positive; 17、Urine drug-of-abuse testing positive; 18、Any other factor that makes the subject not suitable for the trial as indicated by the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Banapenem; 2000 mg group is performed firstly. After completion of observation and confirming that the drug can be safely tolerated, study on 3000 mg group is then performed	Drug: Banapenem; 2000 mg group is performed firstly. After completion of observation and confirming that the drug can be safely tolerated, study on 3000 mg group is then performed
Placebo Comparator: placebo; sodium chloride injection Once daily for 7 days	Drug: sodium chloride; sodium chloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC(0-t) of Benapenem	AUC(0-t) is the area under the curve from time 0 to t	Pre dose and 0.25,1,1.25,1.5, 2, 3,5,8,12, 24,72,96,120,144,144.5,145,145.25,145.5,146,147,149,152,156,168,180,192hours after first Dosing
Maximum observed plasma concentration (Cmax) of Benapenem	Maximum observed plasma concentration (Cmax) of Benapenem in healthy subjects	Pre dose and 0.25,1,1.25,1.5, 2, 3,5,8,12, 24,72,96,120,144,144.5,145,145.25,145.5,146,147,149,152,156,168,180,192hours after first Dosing
Time to maximum observed plasma concentration (tmax) of Benapenem	Time to maximum observed plasma concentration (tmax) of Benapenem in healthy subjects	Pre dose and 0.25,1,1.25,1.5, 2, 3,5,8,12, 24,72,96,120,144,144.5,145,145.25,145.5,146,147,149,152,156,168,180,192hours after first Dosing
Time to elimination half-life (t1/2) of Benapenem	Time to elimination half-life (t1/2) of Benapenem in healthy subjects	Pre dose and 0.25,1,1.25,1.5, 2, 3,5,8,12, 24,72,96,120,144,144.5,145,145.25,145.5,146,147,149,152,156,168,180,192hours after first Dosing

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of subjects with clinically significant findings in vital signs	Vitals signs such as systolic and diastolic blood pressure, heart rate, and pulse rate will be measured in a semi-supine position after 5 minutes of rest	Screening, Day1, Day2, Day3, Day4, Day5, Day6, Day7, Day8, Day9, Day10 after Dosing
Number of subjects with clinically significant findings in laboratory parameters	Hematology and Clinical Chemistry and Urine routine abnormalities will be monitored	Screening, Day1, Day2, Day3, Day4, Day5, Day6, Day7, Day8, Day9, Day10 after Dosing
Number of subjects with clinically significant 12-lead ECGs	Single 12-lead ECGs will be obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTcF intervals.	Screening, Day1, Day2, Day4, Day5,Day7, Day8, Day10 after Dosing
Number of subjects with adverse events and serious adverse events	All adverse events will be monitored in each group subjects	From Screening to Day 10 after dosing

Collaborators and Investigators

• Sponsor: Sihuan Pharmaceutical Holdings Group Ltd.
• Investigators: Principal Investigator: yuan lv, Doctor, Peking University first hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): December 16, 2019
• Primary Completion (Anticipated): September 30, 2020
• Study Completion (Anticipated): December 30, 2020

Study Registration Dates

• First Submitted: December 13, 2019
• First Submitted That Met QC Criteria: December 13, 2019
• First Posted (Actual): December 16, 2019

Study Record Updates

• Last Update Posted (Actual): December 16, 2019
• Last Update Submitted That Met QC Criteria: December 13, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 5081-Ⅰ-1005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No