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

MedImmune

Status and phase

Completed

Phase 1

Conditions

Respiratory Syncytial Virus Infections

Treatments

Biological: MEDI-524 (Numax-TM)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00192465

MI-CP101

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

18 to 49 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 5 patient groups

1

Experimental group

Description:

MEDI-524 (Numax-TM)

Treatment:

Biological: MEDI-524 (Numax-TM)

2

Experimental group

Description:

MEDI-524 (Numax-TM)

Treatment:

Biological: MEDI-524 (Numax-TM)

3

Experimental group

Description:

MEDI-524 (Numax-TM)

Treatment:

Biological: MEDI-524 (Numax-TM)

4

Experimental group

Description:

MEDI-524 (Numax-TM)

Treatment:

Biological: MEDI-524 (Numax-TM)

5

Experimental group

Description:

MEDI-524 (Numax-TM)

Treatment:

Biological: MEDI-524 (Numax-TM)

Trial contacts and locations

1

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