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CompletedNCT03588156Updated Jul 17, 2018

Single-dose PK Study of Benapenem In Healthy Subjects

A Phase 1 interventional study of Benapenem and Placebo in Healthy Subject, sponsored by Sihuan Pharmaceutical Holdings Group Ltd.. Completed. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-07-17.

Sponsored by Sihuan Pharmaceutical Holdings Group Ltd. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 2 months after the study started (first participant enrolled Mar 2015, registered May 2018).
Phase
Phase 1
Study type
Interventional
Enrollment
98
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

To design 11 dose groups within 62.5 mg \~ 4000 mg for single-dose tolerability study. A single-center, randomized, blinded, placebo-controlled, dose escalation trial design is adopted. 8 subjects each in 62.5 mg, 125 mg, 3000 mg and 4000 mg dose groups, 10 subjects each in other groups, including 2 placebo-controlled subjects. To be carried out from low-dose group to high-dose group. 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. The test should be stopped in case of serious adverse reactions, or when more subjects experience adverse reactions and have reached termination criteria of the trial, even if the maximum dose has not been reached.

Infusion time is planned to be 30 min in 62.5 mg, 125 mg and 250 mg ; two infusion time, 30 min and 60 min, in 500 mg, 1000 mg and 2000 mg groups. If subjects can tolerate 60-min infusion, the same dose group at infusion time of 30 min is added. The 3000 mg and 4000 mg dose groups only receive 60-min infusion for investigation of tolerability.

Read the detailed description

It is planned to design 11 dose groups within 62.5 mg \~ 4000 mg for single-dose tolerability study. A single-center, randomized, blinded, placebo-controlled, dose escalation trial design is adopted. There are 8 subjects each in 62.5 mg, 125 mg, 3000 mg and 4000 mg dose groups, and 10 subjects each in other groups. Each group consists of half males and half females, including 2 placebo-controlled subjects (1 male and 1 female). The trial is carried out from low-dose group to high-dose group. Each subject only receives one dose of test drug, which is dissolved in 100 mL of 0.9% NS, intravenous drip. During the trial, the adverse events of subjects should be closely followed. 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. The test should be stopped in case of serious adverse reactions, or when more subjects experience adverse reactions and have reached termination criteria of the trial, even if the maximum dose has not been reached.

In order to investigate possible effect of infusion rate on the tolerability and to ensure the safety of subjects, the infusion time is planned to be 30 min in 62.5 mg, 125 mg and 250 mg low-dose groups; two infusion time, 30 min and 60 min, in 500 mg, 1000 mg and 2000 mg groups. Under the circumstance that subjects can tolerate 60-min infusion, the same dose group at infusion time of 30 min is added to investigate the possible effect of infusion rate on the tolerability. The 3000 mg and 4000 mg dose groups only receive 60-min infusion for investigation of tolerability.

02

Conditions studied

  • Healthy Subject

Keywords

  • Healthy Subject
  • PK Study
  • Tolerability
  • Safety Evaluation
03

In context

Lead sponsor

Sihuan Pharmaceutical Holdings Group Ltd. is the lead sponsor of 23 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

    1. Male or female healthy subjects, aged 18\~45;
    1. Body weight ≥ 50 kg and body mass index 19.0\~24.0 kg/m2;
    1. 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

Exclusion Criteria:

    1. Regular smoking, alcohol abuse, and drug abuse;
  • 2)Use of drugs known damage to an organ within three months;
  • 3)History of specific allergies, or history of drug allergy, especially those allergic to lactams and excipients of test drug;
  • 4)Febrile illnesses within three days before the screening;
  • 5)Patients with mental illness or psychotic disorder in the past;
  • 6)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.
  • 7)Habitually taking any medication, including traditional Chinese medicine;
  • 8)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;
  • 9)Having participated in other investigational drug trial in the preceding three months;
  • 10)Blood donation for 360 ml or more within three months before the screening;
  • 11)Heart rate \< 50 bpm or > 100 bpm;
  • 12)Systolic blood pressure\<90mmHg or ≥ 140mmHg, diastolic blood pressure ≥ 90 mmHg or \< 60 mmHg;
  • 13)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;
  • 14)Women who are planning to become pregnant within 6 months, or male subjects who are planning to make his spouse pregnant within 6 months;
  • 15)HBsAg, HCV antibody, HIV antibody, and Treponema pallidum antibody positive;
  • 16)Urine drug-of-abuse testing positive;
  • 17)Any other factor that makes the subject not suitable for the trial as indicated by the investigator.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
98 participants (actual)

Study arms

  • Experimental
    Benapenem

    Investigatial Product: Benapenem: 11 group : 62.5mg one dose; 125mg one dose;250mg one dose;500mg one dose 30min infusion;500mg one dose 60min infusion ;1000mg one dose 30min infusion; 1000mg one dose 60min infusion 2000mg one dose 30min infusion;2000mg one dose 60min infusion;3000mg one dose 60min infusion;4000mg one dose 60min infusion

    Drug: Benapenem

  • Placebo comparator
    Placebo

    Placebo control 11 group : 62.5mg one dose;125mg one dose;250mg one dose;500mg one dose 30min infusion;500mg one dose 60min infusion ;1000mg one dose 30min infusion; 1000mg one dose 60min infusion 2000mg one dose 30min infusion;2000mg one dose 60min infusion;3000mg one dose 60min infusion;4000mg one dose 60min infusion

    Drug: Placebo

Interventions

  • DrugBenapenem

    Dose-escalation For 11 level dose groups A1 \~ A11(each 62.5mg/kg, 125mg/kg, 250mg/kg, 500mg/kg, 1000mg/kg 60min infusion, 1000mg/kg 30min infusion, 2000mg/kg 60 min infusion, 2000mg/kg 30min infusion, 3000mg/kg, 4000mg/kg), 10 subjects (8 for the study drug and 2 for placebo) are randomized to each dose group

    Also known as: 5081

  • DrugPlacebo

    Placebo

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Change from Baseline at Day1, Day2, Day4 after dosing

  2. Number of subjects with clinically significant findings in laboratory parameters

    Hematology and clinical chemistry and Urine Routine abnormalities will be monitored

    Time frame: Change from Baseline at Day1, Day2, Day4 after dosing

  3. 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

    Time frame: Change from Baseline at Day1, Day2, Day4 after dosing

Secondary outcomes

  1. AUC(0-24) of Benapenem

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

    Time frame: In each group: Pre dose and 0.25,0.5,0.75,1,1.5, 2, 2.5, 3, 4, 6,8,12, 24hour after dosing

  2. Maximum observed plasma concentration (Cmax) of Benepenem

    Time frame: In each group: Pre dose and 0.25,0.5,0.75,1,1.5, 2, 2.5, 3, 4, 6,8,12, 24hour after dosing

  3. Time to maximum observed plasma concentration (tmax) of Benapenem

    Time frame: In each group: Pre dose and 0.25,0.5,0.75,1,1.5, 2, 2.5, 3, 4, 6,8,12, 24hour after dosing

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 30617093 ↗

Individual participant data

Plan to share: No — no plan to make individual participant data

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 17, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03588156
Lead sponsor
Sihuan Pharmaceutical Holdings Group Ltd.
Responsible party
Sponsor
First posted
Jul 17, 2018
Start date
Mar 11, 2015
Primary completion
Sep 17, 2015
Completion
Sep 17, 2015
Last update
Jul 17, 2018

Study contacts

Yan Zhu, Doctor
principal investigator · Peking University First Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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