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

Study identifier:CD-ID-MEDI4893-1133

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

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

Medical condition

Staphylococcus aureus

Phase

Phase 1

Healthy volunteers

Yes

Study drug

Placebo, MEDI4893

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years - 65 Years

Date

Study Start Date: 01 Jan 2013

Primary Completion Date: 01 May 2014

Study Completion Date: 01 May 2014

Study design

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind
Primary Purpose: Other

Verification:

Verified 01 Jul 2014 by MedImmune, LLC

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

1. Age 18 through 65 years at screening.
2. Written informed consent and any locally required authorization (eg, HIPAA) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations.
3. 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.
4. Weight ≥ 45 kg and ≤ 110 kg at screening.
5. Healthy by medical history and physical examination at screening.
6. Systolic blood pressure (BP) < 140 mm Hg and diastolic BP < 90 mm Hg at screening.
7. Normal electrocardiogram (ECG) at screening.
8. Able to complete the 360-day postdose follow-up period as required by the protocol.

Exclusion Criteria

1. 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.
2. 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.
3. Acute illness at study entry.
4. Fever 99.5F or higher on day of dosing.
5. Any drug therapy within 7 days prior to Day 1.
6. Blood donation in excess of 400 mL within 6 months prior to study entry.
7. Receipt of immunoglobulin or blood products within 6 months prior to study entry.
8. Receipt of any prior investigational drug or investigational vaccine within 120 days prior to investigational product dosing or planned dosing
9. Receipt of any standard vaccine within 14 days prior to investigational product dosing.
10. Previous receipt of a monoclonal antibody.
11. 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.
12. History of allergic disease or reactions likely to be exacerbated by any component of the investigational product.
13. Previous medical history or evidence of an intercurrent illness that may compromise the safety of the subject in the study.
14. Evidence of any systemic disease on physical examination at screening.
15. Evidence of infection (ie, positive laboratory test result) with hepatitis A, B, or C virus or human immunodeficiency virus (HIV) at screening.
16. Any of the following at screening:
a) Hemoglobin < 12.0 g/dL for males and < 11.5 g/dL for females.
b) WBC count < 3,800/mm3.
c) Platelet count < 140,000/mm3.
d) AST, ALT, BUN, serum creatinine > upper limit of normal (ULN).
e) Positive Urine Class A drug screen.
f) Other abnormal laboratory values in the screening panel, which in the opinion of the principal investigator, are judged to be clinically significant or potentially confound study results.
17. Pregnant or nursing mother.
18. Active alcohol or drug abuse or history of alcohol or drug abuse that, in the opinion of the principal investigator, might compromise subject safety, study safety assessments, or ability of subject to comply with study requirements.
19. Concurrent enrollment in another interventional study.

No locations available

Arms	Assigned Interventions
Placebo Comparator: Placebo	Drug: Placebo Placebo Other Name: Placebo
Active Comparator: MEDI4893	Drug: MEDI4893 Human immunoglobulin G1 kappa monoclonal antibody Other Name: Active comparator

Documents available

Trial Results Summaries
Available here

Contacts

Contact

Nicole Martin

[email protected]

Investigators

Principal Investigator

Howard Schwartz

Research Site