Phase 1 Placebo-controlled,Dose-escalation Study to Evaluate the Safety and Pharmacokinetics of MEDI8852 in Adults - MEDI8852

Study identifier:D6000C00001

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase 1 Double-blind, Single-dose, Placebo-controlled, Dose-escalation Study to Evaluate the Safety and Pharmacokinetics of MEDI8852 in Healthy Adults

Medical condition

Influenza

Phase

Phase 1

Healthy volunteers

Yes

Study drug

MEDI8852, Placebo

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years - 65 Years

Date

Study Start Date: 01 Jan 2015

Primary Completion Date: 01 Jun 2015

Study Completion Date: 01 Jun 2015

Study design

Allocation: Randomized
Endpoint Classification: Safety
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Jul 2015 by MedImmune, LLC

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

1. Age 18 through 65 years at the time of screening
2. Weight ≥ 45 kg and ≤ 110 kg at screening
3. Healthy by medical history, physical examination, and baseline safety laboratory studies.
4. Systolic blood pressure (BP) < 140 mm Hg and diastolic BP < 90 mm Hg at screening
5. Electrocardiogram without clinically significant abnormalities at screening
6. Able to complete the follow-up period through Day 101 as required by the protocol
7. Females of childbearing potential who are sexually active with a nonsterilized male partner must use a highly effective method of contraception for at least 28 days prior to the first dose of investigational product and must agree to continue using such precautions through Day 101 of the study

Exclusion Criteria

1.Acute illness, including fever > 99.5°F, on day prior to or day of planned dosing
2. Any drug therapy within 7 days prior to Day 1 (except contraceptives or a single use of acetaminophen, aspirin, antihistamine. and other nutritional supplements that have not been taken for at least 30 days prior to enrollment, are not exclusionary.
3.Blood drawn in excess of a total of 450 mL (1 unit) for any reason within 2 months prior to screening
4.Receipt of immunoglobulin or blood products within 6 months prior to screening
5.Receipt of any vaccine within 14 days prior to investigational product dosing or planned receipt of any influenza vaccine within 100 days after investigational product dosing
6.Either history of active infection with hepatitis B or C or positive test for hepatitis C or for hepatitis B surface antigen at screening
7.Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or serum creatinine above the upper limit of normal or hemoglobin, white blood cell count, or platelet count below the lower limit of normal at screening
8.History of malignancy other than treated non-melanoma skin cancers or locally-treated cervical cancer in previous 5 years
9.Pregnant or nursing mother
10.History of alcohol or drug abuse within the past 2 years tha OR positive Class A drug screen for amphetamines, barbiturates, opiates, or cocaine at screening.

No locations available

Arms	Assigned Interventions
Experimental: MEDI8852 MEDI8852 is a human IgG1 kappa monoclonal antibody (mAb) supplied as 50 mg/mL solution for infusion. MEDI8852 is being evaluated for treatment of patients hospitalized with influenza A.	-
Placebo Comparator: Placebo Solution containing no active ingredients	-

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]