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

NCT02350751 | Completed Phase 1

• 1 other identifier: D6000C00001
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Influenza

Keywords

Influenza, Flu, Flu A, Influenza A

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (6)

• 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

Study Arms (2)

MEDI8852

EXPERIMENTAL

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.

Drug: MEDI8852

Placebo

PLACEBO COMPARATOR

Solution containing no active ingredients

Drug: Placebo

Interventions

MEDI8852 DRUG

MEDI8852

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 through 65 years at the time of screening
• Weight ≥ 45 kg and ≤ 110 kg at screening
• Healthy by medical history, physical examination, and baseline safety laboratory studies.
• Systolic blood pressure (BP) \< 140 mm Hg and diastolic BP \< 90 mm Hg at screening
• Electrocardiogram without clinically significant abnormalities at screening
• Able to complete the follow-up period through Day 101 as required by the protocol
• 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

You may not qualify if:

• Acute illness, including fever \> 99.5°F, on day prior to or day of planned dosing
• Blood drawn in excess of a total of 450 mL (1 unit) for any reason within 2 months prior to screening
• Receipt of immunoglobulin or blood products within 6 months prior to screening
• 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
• Either history of active infection with hepatitis B or C or positive test for hepatitis C or for hepatitis B surface antigen at screening
• 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
• History of malignancy other than treated non-melanoma skin cancers or locally-treated cervical cancer in previous 5 years
• Pregnant or nursing mother
• 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.

Sponsors & Collaborators

• MedImmune LLC: lead

Study Sites (1)

Research Site

Overland Park, Kansas, United States

Location

Related Publications (1)

• 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.

  PMID: 28844541 DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

MEDI8852

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2014
• First Posted: January 30, 2015
• Study Start: January 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: July 13, 2015

Record last verified: 2015-07

Locations

US (1)