Pharmacokinetic, Safety/Tolerability Study of a Single SC Dose of PB1023 Injection in Subjects With Normal and Impaired Renal Function

PhaseBio Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: PB1023 Injection

Study type

Interventional

Funder types

Industry

Identifiers

NCT01478399

PB1023-PT-CL-0003

Details and patient eligibility

About

Primary objective:

To compare the pharmacokinetic profile of Glymera (PB1023) Injection after a single dose administered by subcutaneous injection to subjects with normal renal function and impaired renal function.

Secondary objectives:

To evaluate the safety and tolerability of Glymera (PB1023) Injection administered as a subcutaneous injection in adult subjects with normal renal function and impaired renal function.

Enrollment

16 patients

Sex

All

Ages

18 to 79 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Males and females age 18 - 79 years of age inclusive.
BMI 19 - 40 kg/m2.
Renally Impaired Subjects: In otherwise stable health except for Renal Disease.
Healthy volunteers must have/be: eGFR as calculated by MDRD of ≥ 80 mL/min, and Matched to renally impaired subjects for age (± 15 years), weight (± 15 kg), and if possible BMI, race and gender.
Subjects with renal impairment must have 2 separate eGFR that are within 20% of each other and clinically stable for a minimum of 6 months.
No clinically relevant abnormalities in the results of the laboratory screening or admission evaluation other than those consistent with renal impairment or related disease/disorder in the appropriate subject group as determined by the Investigator.

Exclusion criteria

Currently taking or have taken a GLP -1 agent (e.g., Byetta®, Victoza®) within the past year.
Subjects who have previously received PB1023.
Known allergy or serious adverse effect to an approved or investigational GLP-1 receptor analog/agonist.
Serious Infection within 60 days of admission.
Donation or loss of greater than 400 mL of blood 56 days prior to enrollment.
Unstable cardiovascular disease defined as per protocol.
Clinically significant hepatic dysfunction defined as per protocol.
Female subjects who are pregnant, trying to become pregnant or lactating.
Known history of or active alcohol or drug abuse within 12 months prior to Screening or positive alcohol and/or drug screen.
Positive for Human Immunodeficiency Virus (HIV) antibodies, Hepatitis B surface antigen (HBsAg) or Hepatitis C Virus (HCV) antibodies.
Participating in any other study at time of screening other than observational studies or have received any other investigational drug or device within 30 days or 5 half-lives prior to dosing or are taking part in a non-drug study which in the opinion of the Investigator would interfere with the outcome of the study.