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Study to Evaluate the Pharmacokinetic Characteristics of Pegylated Exenatide Injection (PB-119) in Subjects With Different Degrees of Renal Insufficiency and Matched Subjects With Normal Renal Function | Clinical Trials | Clareo Health

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Study to Evaluate the Pharmacokinetic Characteristics of Pegylated Exenatide Injection (PB-119) in Subjects With Different Degrees of Renal Insufficiency and Matched Subjects With Normal Renal Function

An Open-label Phase I Clinical Study to Evaluate the Pharmacokinetic Characteristics of Single-dose of Pegylated Exenatide Injection (PB-119) in Subjects With Different Degrees of Renal Insufficiency and Matched Subjects With Normal Renal Function

NCT05328843•PegBio Co., Ltd.

View on ClinicalTrials.gov

Summary

This study is a single-dose, parallel grouping, open-label phase I clinical study to evaluate the PK characteristics and safety of single subcutaneous injection of PB-119 in subjects with different degrees of renal insufficiency and matched subjects with normal renal function.

Detailed Description

This study plans to enroll 24 subjects, which are divided into three groups: Group A: subjects with mild renal insufficiency (chronic kidney disease \[CKD\] stage 2); Group B: subjects with moderate renal insufficiency (CKD3 stage 3); Group C: subjects with normal renal function. The estimated glomerular filtration rate (eGFR, mL/min/1.73m2) transformed according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula should be converted into individual glomerular filtration rate (GFR, mL/min) as an indicator of CKD grading, and subjects should be stratified according to different degrees of renal function.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•All subjects included in this study must meet all of the following criteria:
•1. Subjects who voluntarily sign the informed consent form (ICF) before the commencement of relevant activities of this study, can understand the procedures and methods of this study, and are willing to strictly abide by the clinical study protocol to complete this study;
•2. Male subjects: Male subjects should voluntarily take effective contraceptive measures, and should not donate sperm from the screening period to 90 days after the administration of the study drug
•Female subjects must meet one of the following conditions:
•1. Non-fertile women
•2. Fertile women should voluntarily take effective contraceptive measures from the screening period to 90 days after the administration of the study drug;
•3. According to the judgment of the investigators, the subject's physical examination, vital signs examination, 12 lead ECG examination and laboratory examination indicators are suitable for participating in this study;
•Subjects in the renal insufficiency group must also meet the following criteria:
•4. Male or female subjects aged between 18 and 75 years old;
•5. The weight of male subjects should not be less than 50 kg and that of female subjects should not be less than 45 kg. BMI should be between 18 and 30 kg/m2 (including both end values);
+5 more criteria

Exclusion Criteria

•All subjects will not be included in this study if they meet any of the following criteria:
•1. Those with allergic constitution or allergic to any component in PB-119;
•2. Those with previous medical history or family history of Medullary thyroid cancer (MTC) or Multiple endocrine adenomatosis type 2 (MEN2), or serum calcitonin ≥ 50 pg/mL at screening;
•3. Those with serum amylase or lipase \>3 × upper limit of normal (ULN) during the screening period or baseline period or subjects with previous diagnosis of acute/chronic pancreatitis;
•4. Those who had severe gastrointestinal diseases (such as active ulcer, gastroparesis, obstruction pyloric, inflammatory bowel disease, etc.) or underwent gastrointestinal surgery or long-term use of drugs directly affecting gastrointestinal peristalsis due to chronic gastrointestinal diseases within 6 months before screening or during the baseline period are not suitable to participate in this clinical study according to the evaluation of the investigators;
•5. Those with any type of treated or untreated malignancy (whether cured or not) within 5 years before screening or during the baseline period (except basal cell carcinoma of the skin);
•6. Those who have major diseases or surgery within 4 weeks before administration, or those who are expected to be hospitalized due to surgery or other reasons during the study period;
•7. Those with a history of drug abuse or a positive urine drug screening test within 5 years before screening;
•8. Those who smoked more than 10 cigarettes per day on average within 3 months before screening;
•9. Those with an average weekly alcohol intake of more than 14 units (female subjects) or 21 units (male subjects) (1 unit of alcohol is equivalent to 284 mL of beer, 1 glass of 125 mL of wine or 25 mL of spirits) in the 3 months prior to screening or who ingested any alcohol-containing products within 48 hours prior to administration, or those with a positive breath alcohol test;
+21 more criteria

Locations (1)

Jia Miao

Chengdu, Sichuan, China

Key Dates

Start Date

May 1, 2022

Primary Completion Date

October 1, 2022

Completion Date

October 1, 2022

Last Updated

April 14, 2022

Enrollment

ESTIMATED participants

Conditions

Type2Diabetes

Interventions

PB119

DRUG

Contacts

Ying Du, MD,PhD

CONTACT

+8618911797119 ying.du@pegbio.com

Michael Xu, MD,PhD

CONTACT

+86-512-62956129 michael.xu@pegbio.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 14, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study to Evaluate the Pharmacokinetic Characteristics of Pegylated Exenatide Injection (PB-119) in Subjects With Different Degrees of Renal Insufficiency and Matched Subjects With Normal Renal Function

Inclusion Criteria

Exclusion Criteria

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