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

NCT03570970 | Completed Phase 1

• 1 other identifier: 5081-CPK-1003
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

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 clinical study.

Conditions

Healthy Subject

Outcome Measures

Primary Outcomes (4)

• AUC(0-24) of Benapenem

  AUC(0-24) is the area under the curve from time 0 to 24 hour

  Pre dose and 0.25,0.5,0.75,1,1.5, 2, 2.5, 3, 4, 6,8,12, 24hours after Dosing

• Maximum observed plasma concentration (Cmax) of Benapenem

  Maximum observed plasma concentration (Cmax) of Benapenem in healthy subjects

  Pre dose and 0.25,0.5,0.75,1,1.5, 2, 2.5, 3, 4, 6,8,12, 24hours after 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 0.25,0.5,0.75,1,1.5, 2, 2.5, 3, 4, 6,8,12, 24hours after 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 0.25,0.5,0.75,1,1.5, 2, 2.5, 3, 4, 6,8,12, 24hours after Dosing

Secondary Outcomes (4)

• Number of subjects with clinically significant findings in vital signs

  Screening, Day1, Day2, Day4 after Dosing

• Number of subjects with clinically significant findings in laboratory parameters

  Screening, Day1, Day2, Day4 after Dosing

• Number of subjects with clinically significant 12-lead ECGs

  Screening, Day1, Day2, Day4 after Dosing

• Number of subjects with adverse events and serious adverse events

  From Screening to Day 4 after dosing

Study Arms (3)

Banapenem C1 group

EXPERIMENTAL

250mg Once daily for 7

Drug: Banapenem

Banapenem C2group

EXPERIMENTAL

500mg Once daily for 7

Drug: Banapenem

Banapenem C3group

EXPERIMENTAL

1000mg Once daily for 7

Drug: Banapenem

Interventions

Banapenem DRUG

Banapenem to be used anti-infection

Also known as: 5081

Banapenem C1 group; Banapenem C2group; Banapenem C3group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female healthy subjects, aged 18\~45;
• Body weight ≥ 50 kg and body mass index 19.0\~24.0 kg/m2;
• 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;
• Normal or mild abnormalities without clinical significance in the standard 12-lead ECG;
• Signing informed consent form.

You may not qualify if:

• Regular smoking, alcohol abuse, and drug abuse;
• Use of drugs with known damage to an organ within three months;
• History of specific allergies , or history of drug allergy, especially those allergic to lactams and excipients of test drug;
• Febrile illnesses within three days before the screening;
• Patients with mental illness or psychotic disorder in the past;
• Past 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.
• Habitually taking any medication, including traditional Chinese medicine;
• 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;
• Having participated in other investigational drug trial in the preceding three months;
• Blood donation for 360 ml or more within three months before the screening;
• Heart rate\<50bpm or \>100bpm; 12)Systolic blood pressure \<90 mmHg or ≥140 mmHg, diastolic blood pressure ≥90mmHg or \<60mmHg;
• 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;
• Women who are planning to become pregnant within 6 months, or male subjects who are planning to make his spouse pregnant within 6 months;
• HBsAg, HCV antibody, HIV antibody, and Treponema pallidum antibody positive;
• Urine drug-of-abuse testing positive;

Sponsors & Collaborators

• Sihuan Pharmaceutical Holdings Group Ltd.: lead

Related Publications (1)

• Zhao CY, Lv Y, Zhu Y, Wei MJ, Liu MY, Ji XW, Kang ZS, Xia YH, Tian JH, Ma Y, Liu Y. A First-in-Human Safety, Tolerability, and Pharmacokinetics Study of Benapenem in Healthy Chinese Volunteers. Antimicrob Agents Chemother. 2019 Feb 26;63(3):e02188-18. doi: 10.1128/AAC.02188-18. Print 2019 Mar.

  PMID: 30617093 DERIVED

Study Officials

• Yuan Lv, PhD

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: May 17, 2018
• First Posted: June 27, 2018
• Study Start: March 14, 2016
• Primary Completion: June 2, 2016
• Study Completion: June 2, 2016
• Last Updated: June 27, 2018

Record last verified: 2018-05