- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03062774
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
36
Phase
- 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
-
-
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
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male and/or female subjects between the ages of 18~45 years at screening;
- Weight: female weight of ≥45 kg, male weight of ≥50 kg, subject body mass index (BMI) between 19~30 kg/m2 (inclusive);
- 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;
- Fasting blood glucose (FPG) results of ≤ 6.0mmol / L;
- Subjects must be consented before study, and willing to sign the written informed consent;
- Subjects are able to well communicated with investigators, comply with study procedure and complete study.
Exclusion Criteria:
- Specific allergy to investigational drug or any ingredients (citric acid, mannitol, m-cresol);
- Have clinical significant major disease or major surgery within 4 weeks before study initiation.
- 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.
- Have history of gastrointestinal, liver and kidney disease (for example: have liver, kidney or gastrointestinal partial resection surgery );
- Have fever before 3 days of screening;
- 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;
- 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);
- Positive of HIV, hepatitis B surface antigen, hepatitis C, Treponema pallidum antibody test;
- 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);
- Heavily smoker or more than 5 cigarettes per day within 3 months before trial, or any tobacco product used during trial;
- 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;
- Allergy to any food or has special requirement to food, not be able to comply to unify diet;
- Excessive consumption of tea, coffee and / or caffeinated beverages (8 cups or more) per day;
- 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;
- Take any clinical trial investigational medication or participate any drug clinical trial within 3 months before trial;
- Blood donation up to or more than 360ml within 3 months before screening;
- Female subjects who plan pregnancy or male subjects who's spouse plan to be pregnant within 6 months;
- Female subjects who take oral contraceptive within 30 days before and during trial;
- Female who received long-acting estrogen or progestin injections or implants within 6 months before and during the trial;
- Female of childbearing potential had non-protective sexual intercourse with partner within 14 days before and during trial;
- Female who is pregnant or lactating;
- 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 |
Intervention / Treatment |
---|---|
Experimental: PB-119
intervention: PB-119 injection
|
What is the study measuring?
Primary Outcome Measures
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
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
Investigators
- 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.
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)
November 15, 2014
Primary Completion (Actual)
September 13, 2016
Study Completion (Actual)
October 8, 2016
Study Registration Dates
First Submitted
February 14, 2017
First Submitted That Met QC Criteria
February 20, 2017
First Posted (Actual)
February 23, 2017
Study Record Updates
Last Update Posted (Actual)
February 23, 2017
Last Update Submitted That Met QC Criteria
February 20, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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