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

NCT03072407 | Completed Phase 1 FDA Drug

• 1 other identifier: CSP-PB119-US01-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Type2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• the number of AEs and the finding from the physical examination, the abnormal lab results

  include monitoring of AEs, vital signs (blood pressure, pulse rate, respiratory)

  accessed up to 4 weeks

Secondary Outcomes (5)

• PB-119 blood plasma concentration

  accessed up to 4 weeks

• PB-119 antibody

  accessed up to 4 weeks

• Insulin sensitivity (SI)

  accessed up to 4 weeks

• Beta-cell Responsivity Index

  accessed up to 4 weeks

• Disposition Index

  accessed up to 4 weeks

Study Arms (5)

PB-119 injection placebo

PLACEBO COMPARATOR

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

Biological: PB-119 injection placebo

PB-119 injection 25ug

EXPERIMENTAL

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

Biological: PB-119 injection

PB-119 injection 50ug

EXPERIMENTAL

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

Biological: PB-119 injection

PB-119 injection 100ug

EXPERIMENTAL

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

Biological: PB-119 injection

PB-119 injection 200ug

EXPERIMENTAL

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

Biological: PB-119 injection

Interventions

PB-119 injection BIOLOGICAL

PB-119 injection 100ug; PB-119 injection 200ug; PB-119 injection 25ug; PB-119 injection 50ug

PB-119 injection placebo BIOLOGICAL

PB-119 injection placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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;

Sponsors & Collaborators

• PegBio Co., Ltd.: lead

Study Sites (2)

Clinical Pharmacology of Miami, Inc.

Miami, Florida, 33014, United States

Location

Frontage Clinical Services. Inc.

Hackensack, New Jersey, 07601, United States

Location

Study Officials

• Gregory Tracey, Dr.

  Frontage Clinical Services, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: placebo-control , parallel

Study Record Dates

• First Submitted: March 2, 2017
• First Posted: March 7, 2017
• Study Start: November 24, 2015
• Primary Completion: November 2, 2016
• Study Completion: November 15, 2016
• Last Updated: April 20, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)