Continuous Multiple Dose PB-119 Injection in Health Volunteers

NCT03062774 | Completed Phase 1

• 1 other identifier: ICP-2014-07
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Type2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  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 Outcomes (1)

• Determine PB-119 blood concentration

  Day1-8, Day 15, Day 22, Day 29, Day 36-42, Day 46,Day 50, Day 54 and Day 58

Study Arms (1)

PB-119

EXPERIMENTAL

intervention: PB-119 injection

Biological: PB-119 injection

Interventions

PB-119 injection BIOLOGICAL

PB-119

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• PegBio Co., Ltd.: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100191, China

Location

Related Publications (1)

• Cui H, Zhao CY, Lv Y, Wei MJ, Zhu Y, Ma XZ, Xia YH, Tian JH, Ma Y, Liu Y, Zhang P, Xu M. Safety, Pharmacokinetics and Pharmacodynamics of Multiple Escalating Doses of PEGylated Exenatide (PB-119) in Healthy Volunteers. Eur J Drug Metab Pharmacokinet. 2021 Mar;46(2):265-275. doi: 10.1007/s13318-020-00665-x. Epub 2021 Feb 12.

  PMID: 33576936 DERIVED

Study Officials

• Yuan LV

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2017
• First Posted: February 23, 2017
• Study Start: November 15, 2014
• Primary Completion: September 13, 2016
• Study Completion: October 8, 2016
• Last Updated: February 23, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)