A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI4893 in Healthy Adult Subjects

NCT01769417 | Completed Phase 1

• 1 other identifier: CD-ID-MEDI4893-1133
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Staphylococcus Aureus

Outcome Measures

Primary Outcomes (3)

• The occurence of adverse events and serious adverse events.

  From the time of informed consent through 360 days post dose

• Vital Sign Measurements

  blood pressure, heart rate, respiratory rate, temperature

  Pre-dose through Study Day 15

• Clinical Safety lab measurements

  Chemistry, Hematology and urinalysis

  from Day 1 (pre-dose) through 90 days post dose

Secondary Outcomes (2)

• Pharmacokinetic Assessments - Serum

  Pre-dose through 360 days post dose

• Anti Drug Antibody (ADA) Assessments - Serum

  Pre-dose through 360 days post dose

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

MEDI4893

ACTIVE COMPARATOR

Drug: MEDI4893

Interventions

Placebo DRUG

Placebo

Placebo

MEDI4893 DRUG

Human immunoglobulin G1 kappa monoclonal antibody

Also known as: Active comparator

MEDI4893

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 1.
• 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.
• Receipt of immunosuppressive medications in the prior year or any active or prior history of immunodeficiency. Any course of systemic corticosteroids of more than 7 day duration during the prior year excludes a subject.
• History of allergic disease or reactions likely to be exacerbated by any component of the investigational product.
• 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 at screening.
• Evidence of infection (ie, positive laboratory test result) with hepatitis A, B, or C virus or human immunodeficiency virus (HIV) at screening.

Sponsors & Collaborators

• MedImmune LLC: lead

Study Sites (1)

Research Site

Miami, Florida, United States

Location

MeSH Terms

Conditions

Staphylococcal Infections

Interventions

suvratoxumab

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Howard Schwartz, M.D.

  Research Site

  PRINCIPAL INVESTIGATOR

• Hasan Jafri, M.D.

  MedImmune LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2013
• First Posted: January 16, 2013
• Study Start: January 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: July 24, 2014

Record last verified: 2014-07

Locations

US (1)