A Phase I, Randomized, Double-Blind, Single-Dose, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI-557

NCT ID: NCT00578682

Last Updated: 2011-11-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2010-11-30

Brief Summary

To evaluate the safety and tolerability of a single IV dose of MEDI-557.

Detailed Description

The primary objective of this study is to evaluate the safety and tolerability of a single IV dose of MEDI-557 administered to healthy adult subjects in 4 dose cohorts.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Single IV dose of 0.3 mg/kg MEDI-557

Group Type: EXPERIMENTAL

MEDI-557

Intervention Type: BIOLOGICAL

Single IV dose of 0.3 mg/kg

2

Single IV dose of 3 mg/kg MEDI-557

Group Type: EXPERIMENTAL

MEDI-557

Intervention Type: BIOLOGICAL

Single IV dose of 3 mg/kg

3

Single IV dose of 15 mg/kg MEDI-557

Group Type: EXPERIMENTAL

MEDI-557

Intervention Type: BIOLOGICAL

Single IV dose of 15 mg/kg

4

Single IV dose of 30 mg/kg MEDI-557

Group Type: EXPERIMENTAL

MEDI-557

Intervention Type: BIOLOGICAL

Single IV dose of 30 mg/kg

Interventions

MEDI-557

Single IV dose of 3 mg/kg

Intervention Type: BIOLOGICAL

MEDI-557

Single IV dose of 15 mg/kg

Intervention Type: BIOLOGICAL

MEDI-557

Single IV dose of 30 mg/kg

Intervention Type: BIOLOGICAL

MEDI-557

Single IV dose of 0.3 mg/kg

Intervention Type: BIOLOGICAL

Other Intervention Names

motavizumab; motavizumab; motavizumab

Eligibility Criteria

Inclusion Criteria

• Age 18 through 45 years at the time of study entry;
• Weight ≤ 90 kg;
• Healthy by medical history and physical examination;
• Normotensive (systolic blood pressure [BP] < 150 mmHg and diastolic BP <90 mmHg);
• Normal electrocardiogram (ECG) at screening (must occur within 21 days before entry into the study);
• Normal spirometry at screening (must occur within 21 days before entry into the study). Normal spirometry is defined as FEV1 (forced expiratory volume in 1 second) and FVC (forced vital capacity) ≥ 80% predicted and an FEV1/FVC > 70%.
• Written informed consent obtained from the subject;
• Sexually active females, unless surgically sterile, must have used an effective method of avoiding pregnancy (including oral or implanted contraceptives, intrauterine device, female condom with spermicide, diaphragm with spermicide, cervical cap, abstinence, use of a condom with spermicide by the sexual partner or sterile sexual partner) for 14 days prior to study drug dosing, must agree to continue using such precautions for 1 year after administration of study drug, and must have a negative serum pregnancy test within 3 days prior to study drug dosing and a negative urine pregnancy test on the day of study drug administration; and
• Ability to complete follow-up period of 240 days as required by the protocol.

Exclusion Criteria

• Acute illness at study entry;
• Fever ≥ 99.5°F at study entry;
• Any drug therapy within 7 days prior to Study Day 0 (except contraceptives);
• Blood donation in excess of 400 mL within 6 months prior to study entry;
• Receipt of immunoglobulin or blood products within 60 days prior to study entry;
• Receipt of any investigational drug therapy or standard vaccine within 120 days prior to study drug dosing through 240 days after study drug dosing;
• Previous receipt of palivizumab or motavizumab; History of immunodeficiency;
• History of allergic disease or reactions likely to be exacerbated by any component of either study drug;
• Previous medical history or evidence of an intercurrent illness that may compromise the safety of the subject in the study;
• Evidence of any systemic disease on physical examination;
• Evidence of infection (ie, positive laboratory test result) with hepatitis A, B, or C virus or human immunodeficiency virus-1 (HIV-1);
• At screening (must be within 21 days before entry into the study) any of the following: hemoglobin < 12.0 gm/dL, white blood cell count (WBC) < 4,000/mm3, platelet count < 120,000/mm3 (or laboratory normal values); aspartate aminotransferase (AST), alanine aminotransferase (ALT), blood urea nitrogen (BUN), serum creatinine > upper limit of normal (ULN); other abnormal laboratory values in the screening panel which, in the opinion of the principal investigator, are judged to be clinically significant; other abnormal laboratory values in the screening panel which, in the opinion of the principal investigator, are judged to potentially confound analysis of study results;
• Pregnancy, or nursing mother;
• History of alcohol or drug abuse within the past 2 years; or
• History of asthma, seasonal allergies, or exercise-induced wheezing.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

MedImmune LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

MedImmune

Principal Investigators

M. Pamela Griffin, M.D.

Role: STUDY_DIRECTOR

MedImmune LLC

Locations

Covance Daytona Beach

Daytona Beach, Florida, United States

Countries

United States

References

Robbie GJ, Criste R, Dall'acqua WF, Jensen K, Patel NK, Losonsky GA, Griffin MP. A novel investigational Fc-modified humanized monoclonal antibody, motavizumab-YTE, has an extended half-life in healthy adults. Antimicrob Agents Chemother. 2013 Dec;57(12):6147-53. doi: 10.1128/AAC.01285-13. Epub 2013 Sep 30.

Reference Type: DERIVED

PMID: 24080653 (View on PubMed)

Other Identifiers

MI-CP144

Identifier Type: -

Identifier Source: org_study_id