Clinical trial NCT02114268: A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI8897 in Healthy Adults
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI8897 in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Respiratory Syncytial Virus Infections
Keywords: Respiratory Syncytial Virus, RSV
Lead sponsor: MedImmune LLC
Sponsor class: INDUSTRY
First posted: 2014-04-15
Enrollment: 342
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: 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.

Eligibility criteria: Key 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

Key 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

Primary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
timeFrame: From start of study drug administration up to Day 391 (Day 361 +/- 30 days)
Secondary outcomes:
measure: Time to Reach Maximum Observed Serum Concentration (Tmax) of MEDI8897
timeFrame: 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
measure: Maximum Observed Serum Concentration (Cmax) for MEDI8897
timeFrame: 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
measure: Area Under the Serum Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) for MEDI8897
timeFrame: 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
measure: Terminal Phase Elimination Half Life (t1/2) for MEDI8897
timeFrame: 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
measure: Systemic Clearance (CL) for MEDI8897
timeFrame: 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
measure: Volume of Distribution (Vz) for MEDI8897
timeFrame: 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
measure: Number of Participants With Positive Anti-Drug Antibody (ADA)
timeFrame: Predose and Day 15, 31, 91, 181, 271 and 361
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Research Site
state: Kansas
Study officials:
affiliation: MedImmune LLC
name: M. Pamela Griffin, MD
role: STUDY_DIRECTOR
affiliation: Study Site
name: Martin Kankam, MD, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.