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A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI8897 in Healthy Adults

NCT ID: NCT02114268

Last Updated: 2016-11-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

342 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2015-06-30

Brief Summary

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The purpose of this study was to evaluate the safety, tolerability and pharmacokinetics of an extended half-life anti-respiratory syncytial virus (RSV) monoclonal antibody compared to placebo when administered to healthy adult participants.

Detailed Description

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This was a phase 1, randomized, double-blind, placebo-controlled, dose-escalation study to evaluate the safety, tolerability and pharmacokinetics of MEDI8897 compared to placebo when administered to healthy adult participants. There were 136 participants randomized to receive MEDI8897 or placebo at one site. Investigational product was delivered intravenously (IV) to 3 cohorts and intramuscularly (IM) to 2 cohorts. 4 different dose levels of investigational product were evaluated across the 5 cohorts. Participants were followed for approximately 1 year.

Conditions

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Respiratory Syncytial Virus Infections

Keywords

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Respiratory Syncytial Virus, RSV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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MEDI8897 300 milligram (mg) Intravenous (IV)

Participants received a single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.

Group Type EXPERIMENTAL

MEDI8897 Intravenous

Intervention Type DRUG

Participants received a single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.

MEDI8897 1000 mg IV

Participants received a single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.

Group Type EXPERIMENTAL

MEDI8897 Intravenous

Intervention Type DRUG

Participants received a single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.

MEDI8897 3000 mg IV

Participants received a single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.

Group Type EXPERIMENTAL

MEDI8897 Intravenous

Intervention Type DRUG

Participants received a single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.

MEDI8897 100 mg Intramuscular (IM)

Participants received a single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.

Group Type EXPERIMENTAL

MEDI8897 Intramuscular

Intervention Type DRUG

Participants received a single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.

MEDI8897 300 mg IM

Participants received a single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.

Group Type EXPERIMENTAL

MEDI8897 Intramuscular

Intervention Type DRUG

Participants received a single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.

Placebo

Participants received placebo on Day 1.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Participants received placebo on Day 1.

Interventions

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MEDI8897 Intravenous

Participants received a single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.

Intervention Type DRUG

Placebo

Participants received placebo on Day 1.

Intervention Type DRUG

MEDI8897 Intravenous

Participants received a single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.

Intervention Type DRUG

MEDI8897 Intravenous

Participants received a single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.

Intervention Type DRUG

MEDI8897 Intramuscular

Participants received a single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.

Intervention Type DRUG

MEDI8897 Intramuscular

Participants received a single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age 18 through 49 years and in good health by history, physical exam, and labs
* Weight greater than or equal to (\>=) 45 kilogram (kg) and less than or equal to (\<=) 110 kg at Screening
* Written informed consent prior to performing any protocol related procedures, including Screening evaluations
* Ability to complete the Follow-up period of 360 days

Exclusion Criteria

* Acute illness including fever \>= 99.5 Fahrenheit (°F) on day of dosing
* Any drug therapy within 7 days prior to Day 1 (except contraceptives)
* Receipt of any investigational drug therapy within 120 days prior to investigational product dosing through 360 days after investigational product dosing
* Previous receipt of a monoclonal antibody (mAb)
* Pregnant or nursing mother
* Concurrent enrollment in another interventional study
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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MedImmune LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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M. Pamela Griffin, MD

Role: STUDY_DIRECTOR

MedImmune LLC

Martin Kankam, MD, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Study Site

Locations

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Research Site

Overland Park, Kansas, United States

Site Status

Countries

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United States

References

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Griffin MP, Khan AA, Esser MT, Jensen K, Takas T, Kankam MK, Villafana T, Dubovsky F. Safety, Tolerability, and Pharmacokinetics of MEDI8897, the Respiratory Syncytial Virus Prefusion F-Targeting Monoclonal Antibody with an Extended Half-Life, in Healthy Adults. Antimicrob Agents Chemother. 2017 Feb 23;61(3):e01714-16. doi: 10.1128/AAC.01714-16. Print 2017 Mar.

Reference Type DERIVED
PMID: 27956428 (View on PubMed)

Other Identifiers

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D5290C00001

Identifier Type: -

Identifier Source: org_study_id