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COMPLETEDPHASE1

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

Phase 1 Open-Label Pharmacokinetic, Safety and Tolerability Study of a Single Subcutaneous Dose of Glymera (PB1023) Injection in Subjects With Normal Renal Function and Subjects With Impaired Renal Function

NCT01478399•PhaseBio Pharmaceuticals Inc.

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 79 years

Sex

ALL

Healthy Volunteers

Yes

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.
+1 more criteria

Locations (2)

Prism Research

Saint Paul, Minnesota, United States

New Orleans Center for Clinical Research

Knoxville, Tennessee, United States

Key Dates

Start Date

December 1, 2011

Primary Completion Date

October 1, 2012

Completion Date

October 1, 2012

Last Updated

April 15, 2013

Enrollment

ACTUAL participants

Conditions

Diabetes Mellitus, Type 2

Interventions

PB1023 Injection

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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 15, 2013Data 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.

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

Inclusion Criteria

Exclusion Criteria

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