Continuous Multiple Dose PB-119 Injection in Health Volunteers

February 20, 2017 updated by: PegBio Co., Ltd.

The Safety, Tolerability, Pharmacokinetic and Pharmacodynamics Study of Continuous Multiple Dose PB-119 Injection in Health Volunteers

This is an open label, multiple dose study, pharmacokinetic and pharmacodynamics studies will be performed at the same time with tolerability study. Three dose arms are designed, 12 subjects will be enrolled in each arm, will equal number of males and females.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Pharmacokinetic and pharmacodynamics studies were performed in parallel with PB-119 25μg、50μg、and 100μg dose escalation tolerability study, plasma samples were collected to determine drug concentration and pharmacodynamics parameters. The study duration of each arm was 8 weeks, study medication was given about 8:00 a.m. on day 1 of each week, totally 6 times, and subject was followed until 15 days after last dose (50 days of study) and then study can be completed.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100191
        • Peking University First Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male and/or female subjects between the ages of 18~45 years at screening;
  2. Weight: female weight of ≥45 kg, male weight of ≥50 kg, subject body mass index (BMI) between 19~30 kg/m2 (inclusive);
  3. Pretrial physical examination, blood routine test, urine routine test, liver and kidney function and related laboratory examination results are normal or mildly abnormal but determined by investigator as no clinical significance;
  4. Fasting blood glucose (FPG) results of ≤ 6.0mmol / L;
  5. Subjects must be consented before study, and willing to sign the written informed consent;
  6. Subjects are able to well communicated with investigators, comply with study procedure and complete study.

Exclusion Criteria:

  1. Specific allergy to investigational drug or any ingredients (citric acid, mannitol, m-cresol);
  2. Have clinical significant major disease or major surgery within 4 weeks before study initiation.
  3. Have any clinical significant major disease history or medical history of circulatory system, endocrine system, nervous system disease or hematology, immunology, psychiatric diseases and metabolic disorders etc.
  4. Have history of gastrointestinal, liver and kidney disease (for example: have liver, kidney or gastrointestinal partial resection surgery );
  5. Have fever before 3 days of screening;
  6. The screening laboratory tests (blood routine test, urine routine test, blood biochemical tests, etc.) were determined by investigator as abnormal with clinical significance within 2 weeks before study initiation;
  7. Pretrial electrocardiogram and vital signs were determined as clinically significant abnormal by investigator (systolic blood pressure <90 mmHg or ≥ 140 mmHg, diastolic blood pressure <60 mmHg or ≥ 90 mmHg; heart rate <50 bpm or> 100 bpm);
  8. Positive of HIV, hepatitis B surface antigen, hepatitis C, Treponema pallidum antibody test；
  9. Alcoholic or frequent drinkers within 6 months before trial, ie more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40% alcohol contented spirit or 150 mL of wine);
  10. Heavily smoker or more than 5 cigarettes per day within 3 months before trial, or any tobacco product used during trial;
  11. Drug abusers or those who have used soft drugs (e.g. marijuana) 3 months prior to the trial or those who took hard drugs (e.g. cocaine, phencyclidine, etc.) one year before and during the trial;
  12. Allergy to any food or has special requirement to food, not be able to comply to unify diet;
  13. Excessive consumption of tea, coffee and / or caffeinated beverages (8 cups or more) per day;
  14. Take any medications that may affect test results, such as antibiotics, non-steroidal anti-inflammatory drugs, antacids containing aluminum or magnesium, diuretics, anticoagulants, central nervous system inhibitors, and any drug that may possibly affect the absorption of the drug within 2 weeks before screening;
  15. Take any clinical trial investigational medication or participate any drug clinical trial within 3 months before trial;
  16. Blood donation up to or more than 360ml within 3 months before screening;
  17. Female subjects who plan pregnancy or male subjects who's spouse plan to be pregnant within 6 months;
  18. Female subjects who take oral contraceptive within 30 days before and during trial;
  19. Female who received long-acting estrogen or progestin injections or implants within 6 months before and during the trial;
  20. Female of childbearing potential had non-protective sexual intercourse with partner within 14 days before and during trial;
  21. Female who is pregnant or lactating;
  22. Subject who cannot complete study due to other reason or determined by investigators as inappropriate to participate this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: PB-119
intervention: PB-119 injection
Biological: PB-119 injection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time Frame: Change from Baseline lab value at 50 days
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
Change from Baseline lab value at 50 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Determine PB-119 blood concentration
Time Frame: Day1-8, Day 15, Day 22, Day 29, Day 36-42, Day 46,Day 50, Day 54 and Day 58
Number of PB-119 blood concentration
Day1-8, Day 15, Day 22, Day 29, Day 36-42, Day 46,Day 50, Day 54 and Day 58

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
PegBio Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yuan LV, Peking University First Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 15, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 13, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 8, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 14, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 23, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 23, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ICP-2014-07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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