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

Completed · Phase 1 · Has a placebo group

Conditions studied: Type2 Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT03072407

Run by

PegBio Co., Ltd.

People needed

40

Starts

2015-11-24

Expected to finish

2016-11-15

Last updated by the study team

2018-04-20

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).
• In good general health as determined by the investigator at screening evaluation
• Male and/or female subjects between the ages of 18 and 70 years, inclusive;
• Are capable of giving informed consent and complying with study procedures;
• Body Mass Index (BMI) of approximately 22 to 40 kg/m2;
• Fasting C-peptide test result must be >0.4 nmol/L;
• HbA1c ≥6.5 % and ≤12%;
• Female subjects must have a negative urine pregnancy test result prior to enrollment.
• Nonsmoker,
• Willing and able to adhere to study restrictions and to be confined at the clinical research center.

You may not qualify if…

• Subjects with a personal or family history of medullary thyroid carcinoma (MTC) or in subjects with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2);
• Screening fasting blood glucose ≤100 or ≥270 mg/dL
• Type 1 diabetes mellitus, or latent autoimmune diabetes in adults; diabetic neuropathy, retinopathy or nephropathy;
• Previous treatment with an approved or investigational GLP-1 mimetic;
• Patients treated with any investigational drugs within 6 weeks of screening;
• Subjects with pancreatitis;
• Clinically significant gastrointestinal disorder
• History or symptoms of clinically significant cardiovascular disease, particularly coronary artery disease, arrhythmias, atrial tachycardia,
• Uncontrolled hypertension at screening;
• History of clinically significant central nervous system disease including: transient ischemic attack, stroke, seizure disorder, depression,
• History of liver disease
• History of clinically significant renal disease
• Uncontrolled severe dyslipidemia;
• Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibody;
• A hospital admission or major surgery within 30 days prior to screening;
• A history of prescription drug abuse, or illicit drug use within 6 months prior to screening;
• A history of alcohol abuse according to medical history within 6 months prior to screening;
• A positive screen for alcohol, or drugs of abuse;
• An unwillingness or inability to comply with food and beverage restrictions during study participation;
• Use of prescription or over-the-counter (OTC) medications, and herbal An
• Unwillingness of male participants to use appropriate contraceptive measures if engaging in sexual intercourse with a female partner of childbearing potential. Appropriate measures include use of a condom and spermicide and, for female partners, use of an intrauterine device (IUD), diaphragm with spermicide, oral contraceptives, injectable progesterone, progesterone subdermal implants, or a tubal ligation. Sexual intercourse with pregnant or lactating women is prohibited

Where it is running

• Clinical Pharmacology of Miami, Inc. — Miami, Florida, United States
• Frontage Clinical Services. Inc. — Hackensack, New Jersey, United States

Full record on ClinicalTrials.gov

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