A Phase I, Open Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single-Dose Subcutaneous Administration of MEDI-528, a Humanized Monoclonal Anti-Interleukin-9 Antibody, in Healthy Adult Volunteers

MedImmune LLC1 site in 1 country29 target enrollmentJune 2005

ConditionsHealthy

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Healthy
Sponsor: MedImmune LLC
Enrollment: 29
Locations: 1
Primary Endpoint: Incidence of Changes From Baseline in the Day 28 Magnetic Resonance Imaging (MRI) of the Brain
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

A Phase I studyto evaluate the safety and tolerability of escalating subcutaneous (SC) doses of MEDI-528 in to healthy adult volunteers.

Detailed Description

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

Registry

clinicaltrials.gov

Start Date

June 2005

End Date

July 2006

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

MedImmune LLC

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Males and females age 19 up to, and including, 49 years of age at the time of the first dose of study drug
•Weight less than 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 two years post-menopausal or an FSH≥40 mIu/mL, must use an effective method of avoiding pregnancy (including oral, injectable, transdermal, 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 the study period of 84 days. 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 Study Day 84 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 the 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
•Willing to forego vigorous activity 1 - 2 days before dosing, and before each study visit.

Exclusion Criteria

•Acute illnesses or evidence of significant active infection, such as fever greater than or equal to 38.0 C (100.5°F) at the start of the study
•Use of prescription medications, other than oral contraceptives, in the 28-day period before Study Day 0
•Any blood donation or significant loss of blood within 6 months of time of entry into the study
•History of immunodeficiency or receipt of immunosuppressive drugs
•History of allergy or reaction to any component of the MEDI-528 formulation
•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, neurologic abnormality, lymphadenopathy, or splenomegaly upon 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 or standard vaccine therapy, other than vaccination for influenza, 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)

Outcomes

Primary Outcomes

Incidence of Changes From Baseline in the Day 28 Magnetic Resonance Imaging (MRI) of the Brain

Time Frame: Days 0 and 28

Number of participants with changes from baseline in the Day 28 MRI of the brain

Incidence of Serious Adverse Events

Time Frame: Days 0 - 84

Number of participants experiencing serious adverse events

Incidence of Adverse Events

Time Frame: Days 0 - 84

Number of participants experiencing adverse events (includes both adverse events and serious adverse events)

Incidence of Abnormal Troponin Levels

Time Frame: Days 0, 1, 7, 14, and 28

Number of participants with troponin levels greater than upper limit of normal

Incidence of Clinically Significant Changes From Baseline in Neurologic Exam

Time Frame: Days 0, 7, 14, 21, 28, 42, and 84

Number of participants with clinically significant changes from baseline in neurologic exam

Secondary Outcomes

Incidence of Anti-drug Antibodies (ADA) to MEDI-528(Days 0, 14, 28, 42, and 84)
Time to Observed Maximum Serum Concentration (Tmax)(Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84)
Observed Maximum Serum Concentration (Cmax)(Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84)
Area Under the Concentration Curve From Time Zero to Last Measurable Concentration [AUC(0-t)](Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84)
Area Under the Concentration Curve From Time Zero to Infinity [AUC(0-infinity)] of MEDI-528(Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84)
Percent of Total Area Under the Concentration Curve Extrapolated From Last Measurable Time to Infinity [AUC(Ext)](Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84)
Total Body Clearance (CL)(Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84)
Half-life (T1/2)(Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84)
Apparent Extravascular Terminal Phase Volume of Distribution (Vz/F)(Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84)