NCT01236404

Completed

Phase 1

Phase 1/2a, Randomized, Double-Blind Placebo-Controlled, Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Response of PB1023 Injection Following Single and Multiple Ascending Subcutaneous Doses in Adult Subjects With Type 2 Diabetes Mellitus (T2DM)

PhaseBio Pharmaceuticals Inc.3 sites in 1 country80 target enrollmentNovember 2010

InterventionsSingle Subcutaneous Dose (Part A) of PB1023 or Placebo (0.9% NaCl)Multiple (Four Weekly) Subcutaneous Injections (Part B) of PB1023 or Placebo (0.9% NaCl)

DrugsSingle Subcutaneous Dose (Part A) of PB1023 or Placebo (0.9% NaCl)Multiple (Four Weekly) Subcutaneous Injections (Part B) of PB1023 or Placebo (0.9% NaCl)

Overview

Phase: Phase 1
Intervention: Single Subcutaneous Dose (Part A) of PB1023 or Placebo (0.9% NaCl)
Conditions: Diabetes Mellitus, Type 2
Sponsor: PhaseBio Pharmaceuticals Inc.
Enrollment: 80
Locations: 3
Primary Endpoint: Safety/Tolerability
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Primary objective:

To evaluate the safety and tolerability of single and multiple ascending doses of PB1023 administered as a subcutaneous (SC) injection in adult subjects with T2DM.

Secondary objectives:

To characterize the pharmacokinetic profile of PB1023 after single and multiple ascending doses of PB1023.
To assess the pharmacodynamic response of various single and multiple doses of PB1023 (daily fasting plasma glucose, and serial glucose, c-peptide and insulin levels in response to a liquid Mixed Meal Tolerance Test (MMTT).

Registry

clinicaltrials.gov

Start Date

November 2010

End Date

November 2011

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

PhaseBio Pharmaceuticals Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Males or post menopausal or surgically sterile females age 18-75 years of age inclusive.
•Diagnosed with T2DM for \> or = 6 months with HbA1c \> or = 6.0% but \< or = 9.0% while taking stable doses of one oral antihyperglycemic agent but \< or = 8.5% when taking two oral antihyperglycemic agents for up to a maximum of 3 months prior to screening.
•Fasting Plasma glucose between 115 mg/dL and 269 mg/dL.
•Fasting C-peptide of \> or = 0.8 ng/mL.
•BMI \< or = 40 kg/m
•Otherwise stable health except for T2DM.

Exclusion Criteria

•Currently taking a non-oral antihyperglycemic agent.
•Have taken a PPARg agonist within 90 days of screening.
•Known allergy to an approved or investigational GLP-1 receptor analog/agonist.
•Unstable cardiovascular disease as defined in clinical protocol.
•History, symptoms or signs of pancreatitis or severe gastrointestinal disease.
•Personal or family history of medullary thyroid tumors history of Multiple Endocrine Neoplasia Syndrome Type
•Poor glucose control as defined in clinical protocol.
•Clinically significant renal and/or hepatic dysfunction as defined in clinical protocol.
•Absolute requirement for corticosteroids or received systemic steroids within 90 days prior to PB1023 administration.
•Pregnant or lactating females.

Arms & Interventions

PB1023 Injection

Subcutaneous injection PB1023

Intervention: Single Subcutaneous Dose (Part A) of PB1023 or Placebo (0.9% NaCl)

PB1023 Injection

Subcutaneous injection PB1023

Intervention: Multiple (Four Weekly) Subcutaneous Injections (Part B) of PB1023 or Placebo (0.9% NaCl)

Placebo (0.9% Sodium Chloride Injection)

Subcutaneous Injection Placebo

Intervention: Single Subcutaneous Dose (Part A) of PB1023 or Placebo (0.9% NaCl)

Placebo (0.9% Sodium Chloride Injection)

Subcutaneous Injection Placebo

Intervention: Multiple (Four Weekly) Subcutaneous Injections (Part B) of PB1023 or Placebo (0.9% NaCl)

Outcomes

Primary Outcomes

Safety/Tolerability

Time Frame: Screening to Final Visit (up to approximately 10 weeks for SAD and 14 weeks for MAD)

Safety will be evaluated by analyses of incidence of adverse events of interest (possibly related to the class of drug) and other adverse events. Vital signs, ECGs and safety laboratory parameters will also be presented.

Secondary Outcomes

Pharmacokinetic Profile(SAD: Pre-dose, 1, 4, 8, and 12 hours post-dose and Day 1, 2, 3, 5, 7, 10, 14, 21 and 28. MAD: Pre-dose, 1, 4, 8, and 12 hours post-dose and Day 1, 2, 3, 5, pre-dose Days 7, 14 and 21 and at 1, 4, 8, and 12 hours post-dose and Day 22, 23, 26, 28, 35, 42,)
Pharmacodynamic Response(Fasting plasma glucose collected the day before dosing and with PK samples, excluding day of dosing. SAD MMTT to occur on day 0 and 2, MAD MMTT to occur on Day 0 and 22 with continuous glucose monitoring on Day -8/-7 to Day 0 and on Day 21 to Day 28.)