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Study to Evaluate the Safety, Tolerability,Immunogenicity, and Pharmacokinetics of MEDI-528 in Healthy Adult Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT00192296
First received: September 12, 2005
Last updated: February 4, 2014
Last verified: February 2014
  Purpose

Phase I study to evaluate the safety and tolerability of escalating single IV doses of MEDI-528.


Condition Intervention Phase
Asthma
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,Immunogenicity, and Pharmacokinetics 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, 7, 14, 21, and 28 ] [ Designated as safety issue: Yes ]
    Number of participants with troponin levels greater than upper limit of normal (> 0.05 ng/mL)

  • 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 14, 28, 42, and 84 ] [ Designated as safety issue: Yes ]
    Number of participants who had ADA detected at each time point

  • Time to Observed Maximum Serum Concentration (Tmax) [ Time Frame: Days 0 (prior to and after the end of the infusion, and at 1, 2, 4, 8, and 12 hours after the end of the infusion), 1, 3, 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 (prior to and after the end of the infusion, and at 1, 2, 4, 8, and 12 hours after the end of the infusion), 1, 3, 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 (prior to and after the end of the infusion, and at 1, 2, 4, 8, and 12 hours after the end of the infusion), 1, 3, 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)] [ Time Frame: Days 0 (prior to and after the end of the infusion, and at 1, 2, 4, 8, and 12 hours after the end of the infusion), 1, 3, 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 (prior to and after the end of the infusion, and at 1, 2, 4, 8, and 12 hours after the end of the infusion), 1, 3, 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, 3, 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, 3, 5, 7, 10, 14, 21, 28, 42, and 84 ] [ Designated as safety issue: No ]
    T1/2 of MEDI-528

  • Terminal Phase Elimination Rate (Vz) [ Time Frame: Days 0, 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84 ] [ Designated as safety issue: No ]
    Vz of MEDI-528


Enrollment: 24
Study Start Date: August 2004
Study Completion Date: March 2005
Primary Completion Date: February 2005 (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, intravenous (IV) dose
Biological: MEDI-528 0.3 mg/kg
MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose
Experimental: MEDI-528 1 mg/kg
MEDI-528 (1 mg/kg) administered as a single, IV dose
Biological: MEDI-528 1 mg/kg
MEDI-528 (1 mg/kg) administered as a single, IV dose
Experimental: MEDI-528 3 mg/kg
MEDI-528 (3 mg/kg) administered as a single, IV dose
Biological: MEDI-528 3 mg/kg
MEDI-528 (3 mg/kg) administered as a single, IV dose
Experimental: MEDI-528 9 mg/kg
MEDI-528 (9 mg/kg) administered as a single, IV dose
Biological: MEDI-528 9 mg/kg
MEDI-528 (9 mg/kg) administered as a single, IV dose

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Males and females age 18 up to and including 49 years of age at the time of the first dose of study drug
  • Weight < 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 one year post-menopausal, must use an effective method of avoiding pregnancy (including oral, injectable, transdermal or implanted contraceptives, IUD, female condom, diaphragm with spermicide, cervical cap,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 84 days after their dose of study drug. 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 84 days 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 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

Exclusion Criteria:

  • Acute illnesses or evidence of significant active infection, such as fever ≥38.0°C (100.5°F) at the start of the study
  • Use of prescription medications, other than contraceptives, in the 28-day period before Study Day 0
  • Blood donation in excess of 400 mL within 6 months of the time of entry into the study
  • History of use of tobacco products within 3 years of Study Day 0 or history of smoking of >10 pack-years
  • History of immunodeficiency or receipt or current use of immunosuppressive drugs including systemic corticosteroids
  • History of allergic disease or reactions likely to be exacerbated by any component of the Study Drug (described in the Investigator's Brochure)
  • 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 on 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 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)
  • Any of the following: CBC: Hgb < 12.0 gm/dL; WBC < 4,000/mm3; platelet count <125,000/mm3 (or laboratory normal values); Na, K, Cl, CO2, AST, ALT, BUN, 4-hour fasting glucose, amylase, lipase, creatinine, troponin > upper limit of normal; other abnormal laboratory values in the screening panel which 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
  • 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 the study drug, before dosing)
  • Nursing mother
  • The presence of any acute or chronic organ-specific condition or any 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: NCT00192296

Locations
United States, Louisiana
MDS Pharma Services
New Orleans, Louisiana, United States
Sponsors and Collaborators
MedImmune LLC
Investigators
Principal Investigator: Ramon Vargas, MD
  More Information

No publications provided

Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT00192296     History of Changes
Other Study ID Numbers: MI-CP105
Study First Received: September 12, 2005
Results First Received: October 17, 2013
Last Updated: February 4, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on November 25, 2014