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

• ClinicalTrials.gov Identifier: NCT02350751
• Recruitment Status: Completed
• First Posted: January 30, 2015
• Last Update Posted: July 13, 2015
• Sponsor: MedImmune LLC
• Information provided by (Responsible Party): MedImmune LLC

Tracking Information

• First Submitted Date: December 23, 2014
• First Posted Date: January 30, 2015
• Last Update Posted Date: July 13, 2015
• Study Start Date: January 2015
• Actual Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 26, 2015)

• Number of Participants with Adverse Events as a Measure of Safety and tolerability of MEDI8852 [ Time Frame: 100 days postdose ]
  Occurrence of adverse events, serious adverse events, adverse events of special interest, and new onset chronic disease.
• Number of Participants with Adverse Events as a Measure of Safety and tolerability of MEDI8852 [ Time Frame: 28 days postdose ]
  Clinical laboratory assessments (ie, serum chemistry, hematology, and urinalysis)

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: January 26, 2015)

• Pharmacokinetics of MEDI8852 in serum: terminal-phase elimination (t½) [ Time Frame: 100 days postdose ]
  This variable will be estimated for MEDI8852 in the IV cohorts where the data allow.
• Pharmacokinetics of MEDI8852 in serum: systemic clearance (CL) [ Time Frame: 100 days postdose ]
  This variable will be estimated for MEDI8852 in the IV cohorts where the data allows.
• Pharmacokinetics of MEDI8852 in serum: time to maximum serum concentration (Cmax) [ Time Frame: 100 days postdose ]
  This variable will be estimated for MEDI8852 in the IV cohorts where the data allow.
• 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) [ Time Frame: 100 days postdose ]
  This variable will be estimated for MEDI8852 in the IV cohorts where the data allow.
• Incidence of anti-drug antibody to MEDI8852 in serum [ Time Frame: 100 days postdose ]
  This variable will be estimated for MEDI8852 in the IV cohorts where the data allow.
• Pharmacokinetics of MEDI8852 in serum:volume at steady state (Vss) [ Time Frame: 100 days postdose ]
  This variable will be estimated for MEDI8852 in the IV cohorts where the data allow.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Phase 1 Placebo-controlled,Dose-escalation Study to Evaluate the Safety and Pharmacokinetics of MEDI8852 in Adults
• 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
• 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.
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Influenza

Intervention

• Drug: MEDI8852
• Drug: Placebo

Study Arms

• 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.
  Intervention: Drug: MEDI8852
• Placebo Comparator: Placebo
  Solution containing no active ingredients
  Intervention: Drug: Placebo

• Publications *: Mallory RM, Ali SO, Takas T, Kankam M, Dubovsky F, Tseng L. A phase 1 study to evaluate the safety and pharmacokinetics of MEDI8852, an anti-influenza A monoclonal antibody, in healthy adult volunteers. Biologicals. 2017 Nov;50:81-86. doi: 10.1016/j.biologicals.2017.08.007. Epub 2017 Aug 23.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 10, 2015): 94
• Original Estimated Enrollment (submitted: January 26, 2015): 40
• Actual Study Completion Date: June 2015
• Actual Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02350751
• Other Study ID Numbers: D6000C00001
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: MedImmune LLC
• Original Responsible Party: Same as current
• Current Study Sponsor: MedImmune LLC
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: MedImmune LLC
• Verification Date: July 2015