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

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ClinicalTrials.gov Identifier: NCT03570970
Recruitment Status : Completed
First Posted : June 27, 2018
Last Update Posted : June 27, 2018
Sponsor:
Information provided by (Responsible Party):
Sihuan Pharmaceutical Holdings Group Ltd.

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.

Condition or disease Intervention/treatment Phase
Healthy Subject Drug: Banapenem Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multiple-dose Tolerability and Pharmacokinetic Studies of Benapenem for Injection in Phase Ib Clinical Healthy Subjects
Actual Study Start Date : March 14, 2016
Actual Primary Completion Date : June 2, 2016
Actual Study Completion Date : June 2, 2016

Arm Intervention/treatment
Experimental: Banapenem C1 group
250mg Once daily for 7
Drug: Banapenem
Banapenem to be used anti-infection
Other Name: 5081

Experimental: Banapenem C2group
500mg Once daily for 7
Drug: Banapenem
Banapenem to be used anti-infection
Other Name: 5081

Experimental: Banapenem C3group
1000mg Once daily for 7
Drug: Banapenem
Banapenem to be used anti-infection
Other Name: 5081




Primary Outcome Measures :
  1. AUC(0-24) of Benapenem [ Time Frame: Pre dose and 0.25,0.5,0.75,1,1.5, 2, 2.5, 3, 4, 6,8,12, 24hours after Dosing ]
    AUC(0-24) is the area under the curve from time 0 to 24 hour

  2. Maximum observed plasma concentration (Cmax) of Benapenem [ Time Frame: 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 in healthy subjects

  3. Time to maximum observed plasma concentration (tmax) of Benapenem [ Time Frame: 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 in healthy subjects

  4. Time to elimination half-life (t1/2) of Benapenem [ Time Frame: 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 in healthy subjects


Secondary Outcome Measures :
  1. Number of subjects with clinically significant findings in vital signs [ Time Frame: Screening, Day1, Day2, Day4 after Dosing ]
    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

  2. Number of subjects with clinically significant findings in laboratory parameters [ Time Frame: Screening, Day1, Day2, Day4 after Dosing ]
    Hematology and Clinical Chemistry and Urine routine abnormalities will be monitored

  3. Number of subjects with clinically significant 12-lead ECGs [ Time Frame: Screening, Day1, Day2, Day4 after Dosing ]
    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.

  4. Number of subjects with adverse events and serious adverse events [ Time Frame: From Screening to Day 4 after dosing ]
    All adverse events will be monitored in each group subjects



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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;
  • Any other factor that makes the subject not suitable for the trial as indicated by the investigator.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03570970


Sponsors and Collaborators
Sihuan Pharmaceutical Holdings Group Ltd.
Investigators
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Principal Investigator: Yuan Lv, PhD Peking University First Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sihuan Pharmaceutical Holdings Group Ltd.
ClinicalTrials.gov Identifier: NCT03570970     History of Changes
Other Study ID Numbers: 5081-CPK-1003
First Posted: June 27, 2018    Key Record Dates
Last Update Posted: June 27, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No