A Phase 1, Randomized, Double-blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI4893, an Extended Half-Life Human Monoclonal Antibody Against Staphylococcus Aureus Alpha Toxin, in Healthy Adult Subjects
Overview
- Phase
- Phase 1
- Intervention
- Placebo
- Conditions
- Staphylococcus Aureus
- Sponsor
- MedImmune LLC
- Enrollment
- 85
- Locations
- 1
- Primary Endpoint
- The occurence of adverse events and serious adverse events.
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
This is a Phase 1, first time in human study enrolling approximately 33 healthy adult subjects (18-65 yrs) from one study site. The purpose of this study is to evaluate the safety, tolerability and PK of MEDI4893 in healthy adult volunteers administered as a single IV dose compared with placebo, across 4 cohorts. The 4 dose cohorts will enroll sequentially. Subjects will be followed for safety from the time of Informed Consent through 360 days post dose.
Detailed Description
This is a phase 1, randomized, double-blind, placebo-controlled, dose-escalation study to evaluate the safety, tolerability and pharmacokinetics of MEDI4893, an extended half-life human monoclonal antibody against Staphylococcus aureus alpha toxin, in healthy adult subjects. Approximately 33 subjects will be enrolled across 4 fixed dose cohorts at 1 study site . This study will last approximately 389 days, constituting a screening period of up to 28 days, 1 day of investigational product administration, and a 360 day safety follow up period.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 18 through 65 years at screening.
- •Written informed consent and any locally required authorization (eg, HIPAA) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations.
- •Females of childbearing age using contraception for at least 28 days prior to receiving the dose of investigational product, and for 1 year after receiving IP.
- •Weight ≥ 45 kg and ≤ 110 kg at screening.
- •Healthy by medical history and physical examination at screening.
- •Systolic blood pressure (BP) \< 140 mm Hg and diastolic BP \< 90 mm Hg at screening.
- •Normal electrocardiogram (ECG) at screening.
- •Able to complete the 360-day postdose follow-up period as required by the protocol.
Exclusion Criteria
- •Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results.
- •Employees of the sponsor, clinical study site, or any other individuals involved with the conduct of the study, or immediate family members of such individuals.
- •Acute illness at study entry.
- •Fever 99.5F or higher on day of dosing.
- •Any drug therapy within 7 days prior to Day
- •Blood donation in excess of 400 mL within 6 months prior to study entry.
- •Receipt of immunoglobulin or blood products within 6 months prior to study entry.
- •Receipt of any prior investigational drug or investigational vaccine within 120 days prior to investigational product dosing or planned dosing
- •Receipt of any standard vaccine within 14 days prior to investigational product dosing.
- •Previous receipt of a monoclonal antibody.
Arms & Interventions
Placebo
Intervention: Placebo
MEDI4893
Intervention: MEDI4893
Outcomes
Primary Outcomes
The occurence of adverse events and serious adverse events.
Time Frame: From the time of informed consent through 360 days post dose
Vital Sign Measurements
Time Frame: Pre-dose through Study Day 15
blood pressure, heart rate, respiratory rate, temperature
Clinical Safety lab measurements
Time Frame: from Day 1 (pre-dose) through 90 days post dose
Chemistry, Hematology and urinalysis
Secondary Outcomes
- Pharmacokinetic Assessments - Serum(Pre-dose through 360 days post dose)
- Anti Drug Antibody (ADA) Assessments - Serum(Pre-dose through 360 days post dose)