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

PegBio Co., Ltd.1 site in 1 country36 target enrollmentNovember 15, 2014

ConditionsType2 Diabetes Mellitus

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Type2 Diabetes Mellitus
Sponsor: PegBio Co., Ltd.
Enrollment: 36
Locations: 1
Primary Endpoint: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

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.

Registry

clinicaltrials.gov

Start Date

November 15, 2014

End Date

October 8, 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

PegBio Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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;