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

This study has been completed.
Sponsor:
Information provided by:
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT00192465
First received: September 13, 2005
Last updated: January 28, 2009
Last verified: January 2009
  Purpose

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 Intervention Phase
Respiratory Syncytial Virus Infections
Biological: MEDI-524 (Numax-TM)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • Safety [ Time Frame: 30 days after patient's final dose of study drug ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics [ Time Frame: Study Day 0 and 60, 90 days after dose 1; and 7, 30, 60, 90 days after dose 2. ] [ Designated as safety issue: No ]
  • Immunogenicity [ Time Frame: 150 days after final dose ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: November 2003
Study Completion Date: November 2004
Primary Completion Date: April 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

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

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.
  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: NCT00192465

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

No publications provided

Responsible Party: Genevieve Lonosky, M.D., MedImmune Inc.
ClinicalTrials.gov Identifier: NCT00192465     History of Changes
Other Study ID Numbers: MI-CP101
Study First Received: September 13, 2005
Last Updated: January 28, 2009
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 21, 2014