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

NCT04200261 | Unknown Phase 1

• 1 other identifier: 5081-Ⅰ-1005
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Number of subjects with clinically significant findings in vital signs

  Screening, Day1, Day2, Day3, Day4, Day5, Day6, Day7, Day8, Day9, Day10 after Dosing

• Number of subjects with clinically significant findings in laboratory parameters

  Screening, Day1, Day2, Day3, Day4, Day5, Day6, Day7, Day8, Day9, Day10 after Dosing

• Number of subjects with clinically significant 12-lead ECGs

  Screening, Day1, Day2, Day4, Day5,Day7, Day8, Day10 after Dosing

• Number of subjects with adverse events and serious adverse events

  From Screening to Day 10 after dosing

Study Arms (2)

Banapenem

EXPERIMENTAL

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

placebo

PLACEBO COMPARATOR

sodium chloride injection Once daily for 7 days

Drug: sodium chloride

Interventions

Banapenem DRUG

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

Banapenem

sodium chloride DRUG

sodium chloride

placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Ten men, ten women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 、 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.

You may not qualify if:

• 、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.

Sponsors & Collaborators

• Sihuan Pharmaceutical Holdings Group Ltd.: lead

Study Sites (1)

Peking university first hospital

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• yuan lv, Doctor

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

yuan lv, Doctor

CONTACT

18813015605; LYU18813015605@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2019
• First Posted: December 16, 2019
• Study Start: December 16, 2019
• Primary Completion: September 30, 2020
• Study Completion: December 30, 2020
• Last Updated: December 16, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)