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Clinical Trial for PB-119 in Healthy Subjects (Phase I)

Primary Purpose

Type II Diabetes

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
PB-119
Sponsored by
PegBio Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type II Diabetes focused on measuring safety,, pharmacokinetics,, Long acting GLP-1 analogue

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Male or female volunteers, ages: between 18-45;
  • Body weight： female >= 45kg, male >=50kg, BMI >=19-24kg/m2
  • Physical examination, blood routine, urine routine, liver and kidney function and related laboratory tests are normal or slightly abnormal but not clinically significant;
  • Read, agree, and sign the informed consent;
  • Be able to communicate with the investigator and finish the study according to the protocol.

Exclusion Criteria （anyone or more of the following):

  • Allergic to the API or excipients used (citric acid, mannitol, Meta-Cresol);
  • Experiencing clinically significant disease or surgery within 4 weeks before the study;
  • Clinically significant disease history in systems including cardiovascular system, endocrine system, neutral system, immunology system, psychiatry，metabolic disorder;
  • Disease history of gastrointestinal tract, liver, and kidney (for example, the Partial resection surgery in GI tract, liver, or kidney);
  • Fever history within 3 days of the screening;
  • Clinical significant abnormality found in laboratory tests (blood, urine routine test) within 2 weeks before study;
  • ECG or vital signs is clinically significant abnormality as judged by the Investigator( systolic blood pressure <90mmHg or ≥140mmHg; diastolic blood pressure<60mmHg or ≥90mmHg; heart rate <50bpm or >100bpm);
  • Antibody test for HIV, BsAg, C hepatitis, or Microspironema pallidum positive;
  • Alcoholics or drink frequently within 6 months of trial (more than 14 unit of alcohol, in which 1 unit is 360mL beers, or 45 ml wine with 40% alcohol content, or 150mL port wine;
  • Addicted to cigarette, tea, coffee or drugs;
  • Have specific requirement for diets (or allergic to any food);
  • Have been administered in the past 2 weeks with any drug (such as antibiotics, anticoagulant, diuretics) that might interfere the PK profile of drug/drug candidate to be used in this study;
  • Participated in any clinical trial in the past 3 months;
  • Donated blood of more than 360 ml in the past 3 months;
  • Plan to be pregnant herself or his spouse in the next 6 months;
  • Females administered with any oral contraceptive 30 days before the study or during the study;
  • Females dosed with long acting estrogen or progestin (injections or implant) 6 months before the study or during the study;
  • Females at childbearing age that had unprotected intercourse 14 days before the study or will have during the study;
  • Female who is pregnant or nursing;
  • Anybody who might not be able to complete the study, or considered not appropriate by the investigator.

Sites / Locations

  • Peking University First Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Exenatide analogue, Injection

Arm Description

PB-119 will be administered once weekly subcutaneously at dosage of 2μg、5μg、10μg、25μg、50μg、100μg、200μg or 400μg.

Outcomes

Primary Outcome Measures

Safety/Adverse Event Outcome Measure

Secondary Outcome Measures

Full Information

First Posted
March 9, 2014
Last Updated
February 13, 2017
Sponsor
PegBio Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02084251
Brief Title
Clinical Trial for PB-119 in Healthy Subjects (Phase I)
Official Title
Safety, Tolerability and Pharmacokinetics of Single Dose of PB-119 in Healthy Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PegBio Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
GLP-1 analogues have been widely used because of their unique advantages (no risk of hypoglycemia) due to their glucose dependent mechanism. Due to the short half-life of peptide in plasma, peptides have to be administered frequently (i.e. BID for Byetta, with Exenatide as API).To improve the patients compliance and reduce potential adverse events associated with GLP-1 analogues, a long acting GLP-1 analogue (PB-119), which may be administered once weekly, was developed by PegBio Inc. In order to provide rational for dosage range to be studied in Phase Ib, the safety profile, tolerance, and pharmacokinetic behavior of PB-119 in healthy subjects will be studied in this randomized, controlled dose escalating trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type II Diabetes
Keywords
safety,, pharmacokinetics,, Long acting GLP-1 analogue

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
N/A
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exenatide analogue, Injection
Arm Type
Experimental
Arm Description
PB-119 will be administered once weekly subcutaneously at dosage of 2μg、5μg、10μg、25μg、50μg、100μg、200μg or 400μg.
Intervention Type
Drug
Intervention Name(s)
PB-119
Primary Outcome Measure Information:
Title
Safety/Adverse Event Outcome Measure
Time Frame
Up to 3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male or female volunteers, ages: between 18-45; Body weight： female >= 45kg, male >=50kg, BMI >=19-24kg/m2 Physical examination, blood routine, urine routine, liver and kidney function and related laboratory tests are normal or slightly abnormal but not clinically significant; Read, agree, and sign the informed consent; Be able to communicate with the investigator and finish the study according to the protocol. Exclusion Criteria （anyone or more of the following): Allergic to the API or excipients used (citric acid, mannitol, Meta-Cresol); Experiencing clinically significant disease or surgery within 4 weeks before the study; Clinically significant disease history in systems including cardiovascular system, endocrine system, neutral system, immunology system, psychiatry，metabolic disorder; Disease history of gastrointestinal tract, liver, and kidney (for example, the Partial resection surgery in GI tract, liver, or kidney); Fever history within 3 days of the screening; Clinical significant abnormality found in laboratory tests (blood, urine routine test) within 2 weeks before study; ECG or vital signs is clinically significant abnormality as judged by the Investigator( systolic blood pressure <90mmHg or ≥140mmHg; diastolic blood pressure<60mmHg or ≥90mmHg; heart rate <50bpm or >100bpm); Antibody test for HIV, BsAg, C hepatitis, or Microspironema pallidum positive; Alcoholics or drink frequently within 6 months of trial (more than 14 unit of alcohol, in which 1 unit is 360mL beers, or 45 ml wine with 40% alcohol content, or 150mL port wine; Addicted to cigarette, tea, coffee or drugs; Have specific requirement for diets (or allergic to any food); Have been administered in the past 2 weeks with any drug (such as antibiotics, anticoagulant, diuretics) that might interfere the PK profile of drug/drug candidate to be used in this study; Participated in any clinical trial in the past 3 months; Donated blood of more than 360 ml in the past 3 months; Plan to be pregnant herself or his spouse in the next 6 months; Females administered with any oral contraceptive 30 days before the study or during the study; Females dosed with long acting estrogen or progestin (injections or implant) 6 months before the study or during the study; Females at childbearing age that had unprotected intercourse 14 days before the study or will have during the study; Female who is pregnant or nursing; Anybody who might not be able to complete the study, or considered not appropriate by the investigator.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuan Lv, Doctor
Organizational Affiliation
No.1 Hospital of Peking University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
32006325
Citation
Cui H, Zhao CY, Lv Y, Wei MJ, Zhu Y, Li Y, Xia YH, Liu Y, Tian JH, Zhang P. Safety, Tolerability and Pharmacokinetics of Single Dose Polyethylene Glycolated Exenatide Injection (PB-119) in Healthy Volunteers. Eur J Drug Metab Pharmacokinet. 2020 Jun;45(3):361-369. doi: 10.1007/s13318-020-00605-9. Erratum In: Eur J Drug Metab Pharmacokinet. 2020 Apr 6;:
Results Reference
derived

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Clinical Trial for PB-119 in Healthy Subjects (Phase I)

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