Clinical trial NCT04200261: Multiple-dose Tolerability and Pharmacokinetic Studies of Benapenem in Clinical Healthy Subjects
Official title: Multiple-dose Tolerability and Pharmacokinetic Studies of Benapenem in Clinical Healthy Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Multiple-dose Tolerability and Pharmacokinetic Studies of Benapenem in Clinical Healthy Subjects
Lead sponsor: Sihuan Pharmaceutical Holdings Group Ltd.
Sponsor class: INDUSTRY
First posted: 2019-12-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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/Ⅲclinical study.


Eligibility criteria: 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.

Primary outcomes:
measure: AUC(0-t) of Benapenem
timeFrame: 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
measure: Maximum observed plasma concentration (Cmax) of Benapenem
timeFrame: 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
measure: Time to maximum observed plasma concentration (tmax) of Benapenem
timeFrame: 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
measure: Time to elimination half-life (t1/2) of Benapenem
timeFrame: 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 outcomes:
measure: Number of subjects with clinically significant findings in vital signs
timeFrame: Screening, Day1, Day2, Day3, Day4, Day5, Day6, Day7, Day8, Day9, Day10 after Dosing
measure: Number of subjects with clinically significant findings in laboratory parameters
timeFrame: Screening, Day1, Day2, Day3, Day4, Day5, Day6, Day7, Day8, Day9, Day10 after Dosing
measure: Number of subjects with clinically significant 12-lead ECGs
timeFrame: Screening, Day1, Day2, Day4, Day5,Day7, Day8, Day10 after Dosing
measure: Number of subjects with adverse events and serious adverse events
timeFrame: From Screening to Day 10 after dosing
Other outcomes:
Locations:
city: Peking
country: China
facility: Peking university first hospital
state: Beijing
Study officials:
affiliation: Peking University First Hospital
name: yuan lv, Doctor
role: PRINCIPAL_INVESTIGATOR
References: