NCT02114268

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
342

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Apr 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

April 3, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 15, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

November 28, 2016

Completed
Last Updated

November 28, 2016

Status Verified

October 1, 2016

Enrollment Period

1.2 years

First QC Date

April 3, 2014

Results QC Date

July 26, 2016

Last Update Submit

October 5, 2016

Conditions

Respiratory Syncytial Virus Infections

Keywords

Respiratory Syncytial Virus, RSV

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)

    An adverse event (AE) is defined as events present at baseline that worsened in intensity after administration of investigational products or events absent at baseline that emerged after administration of study drug, for the period extending to 391 (Day 361 ± 30 days) days after the last dose of study drug.

    From start of study drug administration up to Day 391 (Day 361 +/- 30 days)

Secondary Outcomes (7)

  • Time to Reach Maximum Observed Serum Concentration (Tmax) of MEDI8897

    Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361

  • Maximum Observed Serum Concentration (Cmax) for MEDI8897

    Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361

  • Area Under the Serum Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) for MEDI8897

    Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361

  • Terminal Phase Elimination Half Life (t1/2) for MEDI8897

    Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361

  • Systemic Clearance (CL) for MEDI8897

    Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361

  • +2 more secondary outcomes

Study Arms (6)

MEDI8897 300 milligram (mg) Intravenous (IV)

EXPERIMENTAL

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

Drug: MEDI8897 Intravenous

MEDI8897 1000 mg IV

EXPERIMENTAL

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

Drug: MEDI8897 Intravenous

MEDI8897 3000 mg IV

EXPERIMENTAL

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

Drug: MEDI8897 Intravenous

MEDI8897 100 mg Intramuscular (IM)

EXPERIMENTAL

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

Drug: MEDI8897 Intramuscular

MEDI8897 300 mg IM

EXPERIMENTAL

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

Drug: MEDI8897 Intramuscular

Placebo

PLACEBO COMPARATOR

Participants received placebo on Day 1.

Drug: Placebo

Interventions

PlaceboDRUG

Participants received placebo on Day 1.

Placebo
MEDI8897 IntravenousDRUG

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

MEDI8897 300 milligram (mg) Intravenous (IV)
MEDI8897 IntramuscularDRUG

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

MEDI8897 100 mg Intramuscular (IM)

Eligibility Criteria

Age18 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Overland Park, Kansas, United States

Location

Related Publications (1)

  • 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.

    PMID: 27956428DERIVED

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Condition Hierarchy (Ancestors)

Pneumovirus InfectionsParamyxoviridae InfectionsMononegavirales InfectionsRNA Virus InfectionsVirus DiseasesInfections

Limitations and Caveats

Physical examination parameters of participants were not evaluated.

Results Point of Contact

Title
M. Pamela Griffin, MD, Senior Director
Organization
MedImmune, LLC
information.center@astrazeneca.com
301-398-0000

Study Officials

  • M. Pamela Griffin, MD

    MedImmune LLC

    STUDY DIRECTOR

  • Martin Kankam, MD, PhD, MPH

    Study Site

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

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

Study Record Dates

First Submitted

April 3, 2014

First Posted

April 15, 2014

Study Start

April 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

November 28, 2016

Results First Posted

November 28, 2016

Record last verified: 2016-10

Locations

US(1)