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

Influenza Clinical Trial

— MEDI8852  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02350751
• Other study ID #: D6000C00001
• Status: Completed
• Phase: Phase 1
• First received: December 23, 2014
• Last updated: July 10, 2015
• Start date: January 2015
• Est. completion date: June 2015

Study information

• Verified date: July 2015
• Source: MedImmune LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Influenza

Intervention

Drug:
• MEDI8852

• Placebo

Locations

Country	Name	City	State
United States	Research Site	Overland Park	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
MedImmune LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Adverse Events as a Measure of Safety and tolerability of MEDI8852	Occurrence of adverse events, serious adverse events, adverse events of special interest, and new onset chronic disease.	100 days postdose	Yes
Primary	Number of Participants with Adverse Events as a Measure of Safety and tolerability of MEDI8852	Clinical laboratory assessments (ie, serum chemistry, hematology, and urinalysis)	28 days postdose	Yes
Secondary	Pharmacokinetics of MEDI8852 in serum: terminal-phase elimination (t½)	This variable will be estimated for MEDI8852 in the IV cohorts where the data allow.	100 days postdose	No
Secondary	Pharmacokinetics of MEDI8852 in serum: systemic clearance (CL)	This variable will be estimated for MEDI8852 in the IV cohorts where the data allows.	100 days postdose	No
Secondary	Pharmacokinetics of MEDI8852 in serum: time to maximum serum concentration (Cmax)	This variable will be estimated for MEDI8852 in the IV cohorts where the data allow.	100 days postdose	No
Secondary	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)	This variable will be estimated for MEDI8852 in the IV cohorts where the data allow.	100 days postdose	No
Secondary	Incidence of anti-drug antibody to MEDI8852 in serum	This variable will be estimated for MEDI8852 in the IV cohorts where the data allow.	100 days postdose	No
Secondary	Pharmacokinetics of MEDI8852 in serum:volume at steady state (Vss)	This variable will be estimated for MEDI8852 in the IV cohorts where the data allow.	100 days postdose	No