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MAD Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PB-119 to Subjects With T2DM | Clinical Trials | Clareo Health

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MAD Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PB-119 to Subjects With T2DM

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Sequential Parallel Group, MAD Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PB-119 to Subjects With T2DM

NCT03072407•PegBio Co., Ltd.

View on ClinicalTrials.gov

Summary

This was a phase 1, randomized, double-blind, placebo-controlled, sequential parallel group, MAD study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of four once-weekly subcutaneous doses of PB-119 to subjects with T2DM.

Detailed Description

Dose levels of 25 µg, 50 µg, 100 µg and 200 µg with a dosing regimen of once weekly for 4 consecutive weeks will be evaluated

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patients in whom T2DM has been diagnosed for at least 3 months prior to screening and have not been taking any treatment but have made lifestyle modifications (i.e., diet and exercise) for at least 4 weeks or are taking metformin (with no change in the treatment including dose over the past 2 months).
•2. In good general health as determined by the investigator at screening evaluation
•3. Male and/or female subjects between the ages of 18 and 70 years, inclusive;
•4. Are capable of giving informed consent and complying with study procedures;
•5. Body Mass Index (BMI) of approximately 22 to 40 kg/m2;
•6. Fasting C-peptide test result must be \>0.4 nmol/L;
•7. HbA1c ≥6.5 % and ≤12%;
•8. Female subjects must have a negative urine pregnancy test result prior to enrollment.
•9. Nonsmoker,
•10. Willing and able to adhere to study restrictions and to be confined at the clinical research center.

Exclusion Criteria

•1. Subjects with a personal or family history of medullary thyroid carcinoma (MTC) or in subjects with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2);
•2. Screening fasting blood glucose ≤100 or ≥270 mg/dL
•3. Type 1 diabetes mellitus, or latent autoimmune diabetes in adults; diabetic neuropathy, retinopathy or nephropathy;
•4. Previous treatment with an approved or investigational GLP-1 mimetic;
•5. Patients treated with any investigational drugs within 6 weeks of screening;
•6. Subjects with pancreatitis;
•7. Clinically significant gastrointestinal disorder
•8. History or symptoms of clinically significant cardiovascular disease, particularly coronary artery disease, arrhythmias, atrial tachycardia,
•9. Uncontrolled hypertension at screening;
•10. History of clinically significant central nervous system disease including: transient ischemic attack, stroke, seizure disorder, depression,
+11 more criteria

Locations (2)

Clinical Pharmacology of Miami, Inc.

Miami, Florida, United States

Frontage Clinical Services. Inc.

Hackensack, New Jersey, United States

Key Dates

Start Date

November 24, 2015

Primary Completion Date

November 2, 2016

Completion Date

November 15, 2016

Last Updated

April 20, 2018

Enrollment

ACTUAL participants

Conditions

Type2 Diabetes Mellitus

Interventions

PB-119 injection

BIOLOGICAL

PB-119 injection placebo

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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 20, 2018Data 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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MAD Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PB-119 to Subjects With T2DM

Inclusion Criteria

Exclusion Criteria

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