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Pharmacokinetic Profile of Two Formulations of PB1023 Following Single Subcutaneous Injection in Subjects With Type 2 Diabetes Mellitus

NCT01427257 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2012-10-01

No results posted yet for this study

Summary

Primary objective:

To compare the pharmacokinetic profile of PB1023 after a single dose administered by subcutaneous injection of two formulations (concentrations).

Secondary objectives:

To evaluate the safety and tolerability of two formulations of PB1023 Injection administered as a subcutaneous injection in adult subjects with T2DM.

To evaluate the impact on the pharmacokinetic profile of PB1023 after a single 90 mg dose of formulation B (100 mg/mL) administered cold at 2 to 8°C by subcutaneous injection.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Single Dose PB1023

Single Dose PB1023 Formulation A

DRUG

Single Dose PB1023

Single Dose PB1023 Formulation B

DRUG

Single Dose PB1023

Single Dose PB1023 Formulation B

Sponsors & Collaborators

  • PhaseBio Pharmaceuticals Inc.

    lead INDUSTRY

Principal Investigators

  • Mark Matson, M.D. · Prism Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01427257 on ClinicalTrials.gov