Phase 1 Multicenter, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Response of PE0139 Injection in Adult Subjects With Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
PhaseBio Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT01835730
First received: March 28, 2013
Last updated: October 13, 2014
Last verified: October 2014

March 28, 2013
October 13, 2014
April 2013
May 2014   (final data collection date for primary outcome measure)
  • Change in Vital Signs from baseline (Day 0 Pre-dose) [ Time Frame: Vital signs Day 0, 1, 2, 3, 4, 5, 6, 7, 14 and 28 ] [ Designated as safety issue: Yes ]
    Safety will be evaluated by analyses of the change from baseline in vital signs.
  • Change in ECGs from baseline (Day -1) [ Time Frame: ECG Days 2 and 28 ] [ Designated as safety issue: Yes ]
    Safety will be evaluated by analyses of the change from baseline in 12-lead ECG.
  • Change in Safety Labs from baseline (Pre-dose) [ Time Frame: Safety Labs Days 0, 7 and 28 ] [ Designated as safety issue: Yes ]
    Safety will be evaluated by analyses of the safety laboratory parameters.
  • Incidence and severity of immunogenicity [ Time Frame: Immunogenicity Days 0, 7, 14 and 28 ] [ Designated as safety issue: Yes ]
    Safety will be evaluated by the incidence and severity of immunogenicity.
  • Incidence and severity of adverse events including hypoglycemia [ Time Frame: As reported between Days -10 to 28 ] [ Designated as safety issue: Yes ]
    Safety will be evaluated by the incidence and severity of adverse events including hypoglycemia.
Same as current
Complete list of historical versions of study NCT01835730 on ClinicalTrials.gov Archive Site
  • Pharmacokinetic Profile [ Time Frame: Day 0, 1, 2, 3, 4, 5, 6, and 7 ] [ Designated as safety issue: No ]
    Pharmacokinetic parameters include: Area under the concentration curve from time 0 to infinity (AUC(0-inf)), Area under the concentration curve to the final sample with a concentration greater than or equal to Limit of Quantitation (LOQ) (AUC(0-t)), Time to maximum concentration (Tmax), Maximum serum concentration (Cmax), Elimination rate constant (Lambda-z), Elimination half-life (t1/2), Clearance uncorrected for bioavailability (CL/F), Distribution uncorrected for bioavailability (Vz/F)
  • Pharmacodynamic Response [ Time Frame: FPG Day -10, -4, 0, 1, 2, 3, 4, 5, 6, 7, and 28; 4-pt Glucose and CGM - Day -10 to -7, -6, -5, and -4 to 7 ] [ Designated as safety issue: No ]
    To assess the pharmacodynamic response (time action profile) of various single doses of PE0139. Assessments include Fasting plasma glucose (FPG), 4-point serial glucose monitoring and glucose assessed by continuous glucose monitoring (CGM).
Same as current
Not Provided
Not Provided
 
Phase 1 Multicenter, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Response of PE0139 Injection in Adult Subjects With Type 2 Diabetes Mellitus
Phase 1 Multicenter, Randomized, Double-Blind, Placebo Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Response of PE0139 Injection in Adult Subjects With Type 2 Diabetes Mellitus

This study is a first-in-human randomized, double-blind (Investigator and subject), placebo controlled single ascending dose study that will enroll approximately 40 (6 active/2 placebo per dose group) adult male and female subjects with Type 2 Diabetes Mellitus (T2DM).

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus (T2DM)
  • Drug: PE0139 Injection
  • Drug: Placebo
  • Experimental: PE0139 Injection
    Single subcutaneous injection of PE0139, 40 mg/mL
    Intervention: Drug: PE0139 Injection
  • Placebo Comparator: Placebo
    Single subcutaneous injection of 0.9% Sodium Chloride (NaCl) (Placebo)
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
37
May 2014
May 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Willing and able to sign a written informed consent and follow all study-related procedures;
  • Male and female subjects at least 18 years of age;
  • Male subjects and female subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 30 days after their dose of study drug;
  • Body mass index ≤45 kg/m2;
  • Diagnosed with T2DM and who is currently taking a stable daily dose of a basal insulin (Lantus) plus at least one oral antihyperglycemic agent at a stable dose for 3 months prior to screening.

Exclusion Criteria:

  • Currently taking or have taken within 3 months prior to screening an approved or investigational GLP-1 analogue/agonist (e.g., Victoza®) or pramlintide;
  • Currently taking or have routinely taken, within 3 months prior to screening , a short-acting insulin;
  • Currently taking or have taken, within 3 months prior to screening, a long acting insulin other than Lantus®;
  • Known allergy to, or serious adverse effect caused by an approved, or investigational insulin product or any of its components;
  • Currently taking any of the following medications: thiazide or furosemide diuretics, beta-blockers, estrogens or other hormonal replacement therapy, or other chronic medications with known adverse effects on glucose tolerance levels unless the subject has been on stable doses of such agents for at least 2 months prior to screening and have no planned changes during the study period;
  • History of recurrent severe hypoglycemia (more than 2 episodes within the last 6 months prior to randomization or hypoglycemic unawareness;
  • Malignant disease defined as 1) any history of malignant melanoma or breast cancer and/or 2) history of other types of cancer within the last 5 years prior to screening;
  • Unstable cardiovascular disease defined as one or more of the following: History of stroke, transient ischemic attack, or myocardial infarction within 6 months prior to screening; History of or currently have New York Heart Association Class III-IV heart failure prior to screening; Uncontrolled/sustained hypertension; History or evidence of long QT syndrome or mean triplicate 12-lead electrocardiogram demonstrating QT interval;
  • Clinically significant renal and/or hepatic dysfunction;
  • Absolute requirement for corticosteroids or have received systemic steroids within 3 months prior to Randomization (V5, Day -1). Note: Use of inhaled or topical corticosteroids will be permitted;
  • Pregnant or lactating female subjects;
  • Known history of or active alcohol abuse or use of illicit drugs within 1 year prior to screening;
  • Positive screening for human immunodeficiency virus antibodies, hepatitis B surface antigen, or hepatitis C virus antibodies at V1;
  • Participating in any other study and have received any other investigational medication or device within 30 days prior to Visit 1.
  • Other medical or psychiatric condition which, in the opinion of the Investigator, would place the subject at increased risk.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01835730
PE0139-PT-CL-0001
No
PhaseBio Pharmaceuticals Inc.
PhaseBio Pharmaceuticals Inc.
Not Provided
Principal Investigator: Ronald Brazg, MD Rainier Clinical Research
PhaseBio Pharmaceuticals Inc.
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP