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

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

Sponsors

Lead Sponsor: MedImmune LLC

Source MedImmune LLC
Brief Summary

The purpose of this study is to evaluate the safety and pharmacokinetics of MEDI8852 compared to placebo when administered to healthy adult subjects.

Detailed Description

This is a phase 1, single-dose, double-blind, placebo-controlled, dose-escalation study to evaluate the safety and pharmacokinetics of MEDI8852 compared to placebo when administered to healthy adult subjects. Approximately 40 subjects will be entered to receive treatment across 4 fixed dose cohorts at 1 site. Investigational product will be delivered intravenously (IV). A total of 4 different dose levels of investigational product will be evaluated across the cohorts. Subjects will be followed for approximately 100 days.

Overall Status Completed
Start Date January 2015
Completion Date June 2015
Primary Completion Date June 2015
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Number of Participants with Adverse Events as a Measure of Safety and tolerability of MEDI8852 100 days postdose
Number of Participants with Adverse Events as a Measure of Safety and tolerability of MEDI8852 28 days postdose
Secondary Outcome
Measure Time Frame
Pharmacokinetics of MEDI8852 in serum: terminal-phase elimination (t½) 100 days postdose
Pharmacokinetics of MEDI8852 in serum: systemic clearance (CL) 100 days postdose
Pharmacokinetics of MEDI8852 in serum: time to maximum serum concentration (Cmax) 100 days postdose
Pharmacokinetics of MEDI8852 in serum: area under the concentration time curve from 0 to t (AUC 0-t) and from 0 to infinity (AUC 0-inf) 100 days postdose
Incidence of anti-drug antibody to MEDI8852 in serum 100 days postdose
Pharmacokinetics of MEDI8852 in serum:volume at steady state (Vss) 100 days postdose
Enrollment 94
Condition
Intervention

Intervention Type: Drug

Intervention Name: MEDI8852

Arm Group Label: MEDI8852

Intervention Type: Drug

Intervention Name: Placebo

Arm Group Label: Placebo

Eligibility

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Healthy Volunteers: Accepts Healthy Volunteers

Location
Facility: Research Site
Location Countries

United States

Verification Date

July 2015

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: MEDI8852

Type: Experimental

Description: 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.

Label: Placebo

Type: Placebo Comparator

Description: Solution containing no active ingredients

Acronym MEDI8852
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Triple (Participant, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov