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

NCT ID: NCT03072407

Last Updated: 2018-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-24
• Study Completion Date: 2016-11-15

Brief 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

Conditions

Type2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

PB-119 injection placebo

totally 8 subjects will have PB-119 injection placebo once per weekly for 4 weeks.

Group Type: PLACEBO_COMPARATOR

PB-119 injection placebo

Intervention Type: BIOLOGICAL

PB-119 injection 25ug

totally 8 subjects will have PB-119 injection 25 ug once per weekly for 4 weeks

Group Type: EXPERIMENTAL

PB-119 injection

Intervention Type: BIOLOGICAL

PB-119 injection 50ug

totally 8 subjects will have PB-119 injection 50 ug once per weekly for 4 weeks

Group Type: EXPERIMENTAL

PB-119 injection

Intervention Type: BIOLOGICAL

PB-119 injection 100ug

totally 8 subjects will have PB-119 injection 100 ug once per weekly for 4 weeks

Group Type: EXPERIMENTAL

PB-119 injection

Intervention Type: BIOLOGICAL

PB-119 injection 200ug

totally 8 subjects will have PB-119 injection 200 ug once per weekly for 4 weeks

Group Type: EXPERIMENTAL

PB-119 injection

Intervention Type: BIOLOGICAL

Interventions

PB-119 injection

Intervention Type: BIOLOGICAL

PB-119 injection placebo

Intervention Type: BIOLOGICAL

Eligibility Criteria

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. History of liver disease

12. History of clinically significant renal disease

13. Uncontrolled severe dyslipidemia;

14. Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibody;

15. A hospital admission or major surgery within 30 days prior to screening;

16. A history of prescription drug abuse, or illicit drug use within 6 months prior to screening;

17. A history of alcohol abuse according to medical history within 6 months prior to screening;

18. A positive screen for alcohol, or drugs of abuse;

19. An unwillingness or inability to comply with food and beverage restrictions during study participation;

20. Use of prescription or over-the-counter (OTC) medications, and herbal An

21. 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PegBio Co., Ltd.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gregory Tracey, Dr.

Role: PRINCIPAL_INVESTIGATOR

Frontage Clinical Services, Inc.

Locations

Clinical Pharmacology of Miami, Inc.

Miami, Florida, United States

Frontage Clinical Services. Inc.

Hackensack, New Jersey, United States

Countries

United States

Other Identifiers

CSP-PB119-US01-01

Identifier Type: -

Identifier Source: org_study_id