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

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: PhaseBio Pharmaceuticals Inc.

Criteria

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.