Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single-Dose Subcutaneous Administration of MEDI-528

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT00116168
First received: June 27, 2005
Last updated: October 17, 2013
Last verified: October 2013
  Purpose

A Phase I studyto evaluate the safety and tolerability of escalating subcutaneous (SC) doses of MEDI-528 in to healthy adult volunteers.


Condition Intervention Phase
Healthy
Biological: MEDI-528 0.3 mg/kg
Biological: MEDI-528 1 mg/kg
Biological: MEDI-528 3 mg/kg
Biological: MEDI-528 9 mg/kg
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I, Open Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single-Dose Subcutaneous Administration of MEDI-528, a Humanized Monoclonal Anti-Interleukin-9 Antibody, in Healthy Adult Volunteers

Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • Incidence of Adverse Events [ Time Frame: Days 0 - 84 ] [ Designated as safety issue: Yes ]
    Number of participants experiencing adverse events (includes both adverse events and serious adverse events)

  • Incidence of Abnormal Troponin Levels [ Time Frame: Days 0, 1, 7, 14, and 28 ] [ Designated as safety issue: Yes ]
    Number of participants with troponin levels greater than upper limit of normal

  • Incidence of Clinically Significant Changes From Baseline in Neurologic Exam [ Time Frame: Days 0, 7, 14, 21, 28, 42, and 84 ] [ Designated as safety issue: Yes ]
    Number of participants with clinically significant changes from baseline in neurologic exam

  • Incidence of Changes From Baseline in the Day 28 Magnetic Resonance Imaging (MRI) of the Brain [ Time Frame: Days 0 and 28 ] [ Designated as safety issue: Yes ]
    Number of participants with changes from baseline in the Day 28 MRI of the brain

  • Incidence of Serious Adverse Events [ Time Frame: Days 0 - 84 ] [ Designated as safety issue: Yes ]
    Number of participants experiencing serious adverse events


Secondary Outcome Measures:
  • Incidence of Anti-drug Antibodies (ADA) to MEDI-528 [ Time Frame: Days 0, 14, 28, 42, and 84 ] [ Designated as safety issue: Yes ]
    Number of participants with ADA to MEDI-528

  • Time to Observed Maximum Serum Concentration (Tmax) [ Time Frame: Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84 ] [ Designated as safety issue: No ]
    Tmax of MEDI-528

  • Observed Maximum Serum Concentration (Cmax) [ Time Frame: Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84 ] [ Designated as safety issue: No ]
    Cmax of MEDI-528

  • Area Under the Concentration Curve From Time Zero to Last Measurable Concentration [AUC(0-t)] [ Time Frame: Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84 ] [ Designated as safety issue: No ]
    AUC(0-t) of MEDI-528

  • Area Under the Concentration Curve From Time Zero to Infinity [AUC(0-infinity)] of MEDI-528 [ Time Frame: Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84 ] [ Designated as safety issue: No ]
    AUC(0-infinity) of MEDI-528

  • Percent of Total Area Under the Concentration Curve Extrapolated From Last Measurable Time to Infinity [AUC(Ext)] [ Time Frame: Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84 ] [ Designated as safety issue: No ]
    AUC(ext) of MEDI-528

  • Total Body Clearance (CL) [ Time Frame: Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84 ] [ Designated as safety issue: No ]
    CL of MEDI-528

  • Half-life (T1/2) [ Time Frame: Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84 ] [ Designated as safety issue: No ]
    T1/2 of MEDI-528

  • Apparent Extravascular Terminal Phase Volume of Distribution (Vz/F) [ Time Frame: Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84 ] [ Designated as safety issue: No ]
    Vz/F of MEDI-528


Enrollment: 29
Study Start Date: June 2005
Study Completion Date: July 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MEDI-528 0.3 mg/kg
MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
Biological: MEDI-528 0.3 mg/kg
MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
Experimental: MEDI-528 1 mg/kg
MEDI-528 (1 mg/kg) administered as a single, SC dose
Biological: MEDI-528 1 mg/kg
MEDI-528 (1 mg/kg) administered as a single, SC dose
Experimental: MEDI-528 3 mg/kg
MEDI-528 (3 mg/kg) administered as a single, SC dose
Biological: MEDI-528 3 mg/kg
MEDI-528 (3 mg/kg) administered as a single, SC dose
Experimental: MEDI-528 9 mg/kg
MEDI-528 (9 mg/kg) administered as a single, SC dose
Biological: MEDI-528 9 mg/kg
MEDI-528 (9 mg/kg) administered as a single, SC dose

Detailed Description:

The primary objective of this Phase I study is to evaluate the safety and tolerability of escalating single SC doses of MEDI-528 administered to healthy adult volunteers in four dose groups.

  Eligibility

Ages Eligible for Study:   19 Years to 49 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Males and females age 19 up to, and including, 49 years of age at the time of the first dose of study drug
  • Weight less than 89 kg
  • Written informed consent obtained from the volunteer
  • Healthy by medical history and physical examination
  • Sexually active females, unless surgically sterile or at least two years post-menopausal or an FSH≥40 mIu/mL, must use an effective method of avoiding pregnancy (including oral, injectable, transdermal, abstinence, use of a condom by the sexual partner or sterile sexual partner) for 3 months before the first dose of study drug, and must agree to continue using such precautions through the study period of 84 days. Cessation of birth control after this point should be discussed with a responsible physician. Sexually active males, unless surgically sterile, must likewise use an effective method of birth control (condom or abstinence) and must agree to continue using such precautions through Study Day 84 after their dose of study drug.
  • Use of common over-the-counter medications such as topical corticosteroids, decongestants, antihistamines, analgesics, and antacids is permitted unless, in the opinion of the investigator, it would interfere with either the volunteer's ability to complete the study or interpretation of the study results.
  • Ability to complete the follow-up period of 84 days
  • Willing to forego other forms of experimental treatment during the study period of 84 days
  • Willing to forego vigorous activity 1 - 2 days before dosing, and before each study visit.

Exclusion Criteria:

  • Acute illnesses or evidence of significant active infection, such as fever greater than or equal to 38.0 C (100.5°F) at the start of the study
  • Use of prescription medications, other than oral contraceptives, in the 28-day period before Study Day 0
  • Any blood donation or significant loss of blood within 6 months of time of entry into the study
  • History of immunodeficiency or receipt of immunosuppressive drugs
  • History of allergy or reaction to any component of the MEDI-528 formulation
  • History of substance abuse that, in the opinion of the investigator, may compromise the ability of the study subject to complete the study and follow-up period
  • Evidence of any systemic disease, neurologic abnormality, lymphadenopathy, or splenomegaly upon physical examination
  • Evidence of infection with hepatitis A, B, or C virus or HIV-1
  • Receipt of immunoglobulins or blood products within 60 days of entering the study
  • Receipt of any investigational drug therapy or standard vaccine therapy, other than vaccination for influenza, within 60 days of the first dose of study drug through Study Day 84 (use of licensed agents for indications not listed in the package insert is permitted)
  • Receipt of MEDI-528 in any previous clinical study
  • At Screening (must be within 21 days before study dose administration) any of the following: Hgb, total WBC, platelet count, Na, K, C1, CO2, AST, ALT, BUN, glucose, amylase, lipase, creatinine, or troponin out of the normal range; other abnormal laboratory values in the screening panel that, in the opinion of the principal investigator, are judged to be clinically significant
  • Clinically significant abnormality, as determined by the investigator, on 12-lead electrocardiogram at the time of initial screening
  • Clinically significant abnormalities noted on baseline brain MRI
  • Elective surgery planned during the study period through Study Day 84
  • Pregnancy (sexually active females must have a negative serum pregnancy test on the day of the first dose of study drug, before dosing)
  • Nursing mother
  • The presence of any condition or concern which, in the opinion of the investigator, may interfere with the conduct or interpretation of the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00116168

Locations
United States, Louisiana
MDS Pharma Services
New Orleans, Louisiana, United States, 70119
United States, Nebraska
MDS Pharma Services
Lincoln, Nebraska, United States, 68502
Sponsors and Collaborators
MedImmune LLC
Investigators
Study Director: Barbara White, M.D. MedImmune LLC
  More Information

No publications provided

Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT00116168     History of Changes
Other Study ID Numbers: MI-CP109
Study First Received: June 27, 2005
Results First Received: October 17, 2013
Last Updated: October 17, 2013
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on September 16, 2014