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Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI-524 in Healthy Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00192465
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : January 29, 2009
Information provided by:
MedImmune LLC

Brief Summary:
To provide safety, tolerability, pharmacokinetic, and immunogenicity data for MEDI-524 administered initially as a single dose to healthy adults in a dose escalation safety study before testing in the targeted pediatric population.

Condition or disease Intervention/treatment Phase
Respiratory Syncytial Virus Infections Biological: MEDI-524 (Numax-TM) Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase I, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI-524 (NUMAX TM), a Humanized Enhanced Potency Monoclonal Antibody Against Respiratory Syncytial Virus (RSV), in Healthy Adults
Study Start Date : November 2003
Actual Primary Completion Date : April 2004
Actual Study Completion Date : November 2004

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
MEDI-524 (Numax-TM)
Biological: MEDI-524 (Numax-TM)
Grp.1: 3 mg/kg IV (single dose)

Experimental: 2
MEDI-524 (Numax-TM)
Biological: MEDI-524 (Numax-TM)
Grp. 2: 15 mg/kg IV (single dose)

Experimental: 3
MEDI-524 (Numax-TM)
Biological: MEDI-524 (Numax-TM)
Grp. 3: 30 mg/kg IV (single dose)

Experimental: 4
MEDI-524 (Numax-TM)
Biological: MEDI-524 (Numax-TM)
Grp. 4: 3 mg/kg IM (single dose)

Experimental: 5
MEDI-524 (Numax-TM)
Biological: MEDI-524 (Numax-TM)
Grp.5: 3 mg/kg IM (two doses)

Primary Outcome Measures :
  1. Safety [ Time Frame: 30 days after patient's final dose of study drug ]
  2. Pharmacokinetics [ Time Frame: Study Day 0 and 60, 90 days after dose 1; and 7, 30, 60, 90 days after dose 2. ]
  3. Immunogenicity [ Time Frame: 150 days after final dose ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Volunteers must meet all of the following criteria:
  • Age 18 through 49 years at the time of administration of study drug
  • Weight £90 kg
  • Healthy by medical history and physical examination
  • Normal electrocardiogram (EKG) at screening (must be within 21 days before entry into the study)
  • Written informed consent obtained from the volunteer
  • Sexually active females, unless surgically sterile, must have used an effective method of avoiding pregnancy (including oral 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 14 days prior to the administration of study drug, must agree to continue using such precautions for 30 days after administration of study drug, and must have a negative serum pregnancy test within 7 days prior to the administration of study drug and a negative urine pregnancy test on the day of study drug administration.
  • Ability to complete the follow-up period of 90 days (single-dose groups) or 120 days (two-dose group) as required by the protocol

Exclusion Criteria:

  • Volunteers must have none of the following:
  • Acute illness at the time of entry into the study
  • Temperature ³99.5°F at the time of entry into the study
  • Any drug therapy within 7 days prior to Study Day 0 (except for certain medications such as contraceptives, topical corticosteroids, or infrequent use of over-the-counter headache medications, following approval of the sponsor)
  • Blood donation in excess of 400 mL within 6 months of the time of entry into the study
  • Receipt of immunoglobulin or blood products within 60 days before entry into the study
  • Receipt of any investigational drug therapy or standard vaccine within 120 days before administration of study drug in this protocol through 60 days after the final dose of study drug
  • History of immunodeficiency or receipt of immunosuppressive drugs
  • History of allergic disease or reactions likely to be exacerbated by any component of the study drug
  • Previous medical history or evidence of an intercurrent illness that may compromise the safety of the volunteer in the study
  • Evidence of any systemic disease on physical examination
  • Evidence of infection with hepatitis A, B, or C virus or HIV-1
  • At screening (must be within 7 days before study dose administration) any of the following: CBC: Hgb < 12.0 gm/dL; WBC < 4,000/mm3; platelet count < 120,000/mm3 (or laboratory normal values); AST, ALT, BUN, creatinine > 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.
  • Nursing mother
  • History of alcohol or drug abuse within the past 2 years
  • The presence of any condition or concern which in the opinion of the principal investigator may interfere with the conduct or interpretation of the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00192465

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United States, Florida
SFBC International, Inc
Miami, Florida, United States, 33181
Sponsors and Collaborators
MedImmune LLC
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Study Director: Genevieve Losonsky, MD MedImmune LLC

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Responsible Party: Genevieve Lonosky, M.D., MedImmune Inc. Identifier: NCT00192465     History of Changes
Other Study ID Numbers: MI-CP101
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: January 29, 2009
Last Verified: January 2009

Additional relevant MeSH terms:
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Virus Diseases
Respiratory Syncytial Virus Infections
Pneumovirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections