AzTrials
AzTrials

Health, SubjectivePhase 1NCT03578588

Benapenem PK Phase Ib Multiple-dose Study

A Phase 1 study testing Banapenem in people with Health, Subjective, run by Sihuan Pharmaceutical Holdings Group Ltd..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

A single-center, randomized, open-label, three-period and three-crossover trial design is adopted in the single-dose pharmacokinetic study. 12adult volunteers, are assigned to 3 groups, B1（250mg), B2 (500mg), and B3 (1000mg). Each group of subjects receive single-dose test drug at different dosages in each period. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Health, Subjective
What is being tested?
Banapenem
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
No sites listed yet
Study dates
14 Dec 2015to 13 Jan 2016
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • 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 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.
Show all 17Show fewer
  • 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<50 bpm or >100 bpm;
  • Systolic blood pressure < 90 mmHg or ≥ 140 mmHg, diastolic blood pressure ≥ 90 mmHg or < 60 mmHg;
  • 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.

About this study

Official title: Single-dose Pharmacokinetic, Multiple-dose Tolerability and Pharmacokinetic Studies of Benapenem for Injection in Phase I Clinical Healthy Subjects

A single-center, randomized, open-label, three-period and three-crossover trial design is adopted in the single-dose pharmacokinetic study. 12adult volunteers, are assigned to 3 groups, B1（250mg), B2 (500mg), and B3 (1000mg). Each group of subjects receive single-dose test drug at different dosages in each period.

The tolerability and pharmacokinetic studies are performed simultaneously. Two doses, 250 mg and 500 mg, are proposed for multiple-dose tolerability and pharmacokinetic studies. The subjects are divided into two groups, C1 and C2, 12 subjects in each group, half males and half females. 250 mg group is performed first. Each subject receives only one dose, intravenous drip, once daily, for 7 consecutive days

Read the detailed description

A single-center, randomized, open-label, three-period and three-crossover trial design is adopted in the single-dose pharmacokinetic study. Twelve healthy adult volunteers, half male and female, are enrolled and randomly assigned to three groups, B1, B2, and B3. The subjects in three groups receive three doses, 250 mg, 500 mg and 1000 mg. Each group of subjects receive single-dose test drug at different dosages in each period.

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. Two doses, 250 mg and 500 mg, are proposed for multiple-dose tolerability and pharmacokinetic studies. The subjects are divided into two groups, C1 and C2, 12 subjects in each group, half males and half females. 250 mg group is performed first. After completion of observation and confirming that the drug can be safely tolerated, study on 500 mg group is then performed. Each subject receives only one dose, intravenous drip, once daily, for 7 consecutive days

Being tested
Banapenem
Keywords
single dose, multiple dose, Pharmacokinetic, Tolerability, Healthy Subject, Benapenem

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BanapenemDrug

    Also called 5081

    Twelve healthy adult volunteers, half male and female, are enrolled and randomly assigned to three groups, B1, B2, and B3. The subjects in three groups receive three doses, 250 mg, 500 mg and 1000 mg. Each group of subjects receive single-dose test drug at different dosages in each period. The subjects are divided into two groups, C1 and C2, 12 subjects in each group, half males and half females. 250 mg group is performed first. After completion of observation and confirming that the drug can be safely tolerated, study on 500 mg group is then performed

Study groups in NCT03578588
Study groupRoleWhat they receive
Banapenem B1 groupExperimentalDose in the 1st period 250mg; Dose in the 2nd period 500mg; Dose in the 3rd period 1000mg
Receives: Drug: Banapenem
Banapenem B2groupExperimentalDose in the 1st period 500mg; Dose in the 2nd period 1000mg; Dose in the 3rd period 250mg
Receives: Drug: Banapenem
Banapenem B3groupExperimentalDose in the 1st period 1000mg; Dose in the 2nd period 250mg; Dose in the 3rd period 500mg
Receives: Drug: Banapenem
Banapenem C1groupExperimental250mg Once daily for 7 consecutive days
Receives: Drug: Banapenem
Banapenem C2groupExperimental500mg Once daily for 7 consecutive days
Receives: Drug: Banapenem

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. AUC(0-24) of Benapenem

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

    Measured: Pre dose and 0.25,0.5,0.75,1,1.5, 2, 2.5, 3, 4, 6,8,12, 24,36,48 hours after Dosing

  2. Maximum observed plasma concentration (Cmax) of Benapenem

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

    Measured: Pre dose and 0.25,0.5,0.75,1,1.5, 2, 2.5, 3, 4, 6,8,12, 24,36,48 hours after Dosing

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

    Time to maximum observed plasma concentration (tmax)

    Measured: Pre dose and 0.25,0.5,0.75,1,1.5, 2, 2.5, 3, 4, 6,8,12, 24,36,48 hours after Dosing

  4. Time to elimination half-life (t1/2) of Benapenem

    Time to elimination half-life (t1/2)

    Measured: Pre dose and 0.25,0.5,0.75,1,1.5, 2, 2.5, 3, 4, 6,8,12, 24,36,48 hours after Dosing

Secondary outcomes (4)

  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

    Measured: Screening and Day1, Day 2, 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

    Measured: Screening and Day1, Day 2, Day4 after dosing

  3. Number of subjects with adverse events and serious adverse events

    Measured: Screening and Day1, Day 2, Day4 after dosing

  4. 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, and QT intervals.

    Measured: Screening and Day1, Day 2, Day4 after dosing

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2018
  2. Study start14 Dec 2015
  3. Primary completion13 Jan 2016
  4. Study completion13 Jan 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
A single-center, randomized, open-label, three-period and three-crossover trial design is adopted in the single-dose pharmacokinetic study; A single-center, randomized, open- label, and dose escalation trial design is used in the multiple-dose tolerability and pharmacokinetic studies
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03578588
Sponsor's protocol ID
5081-CPK-1002
Status last verified
May 2018
First submitted
17 May 2018
Last updated
6 Jul 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: there is no plan to make individual participant data to other researchers.

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Banapenem in people with Health, Subjective, run by Sihuan Pharmaceutical Holdings Group Ltd..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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, 24,36,48 hours after Dosing). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03578588, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in