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

Respiratory Syncytial Virus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02114268
• Other study ID #: D5290C00001
• Status: Completed
• Phase: Phase 1
• First received: April 3, 2014
• Last updated: July 10, 2015
• Start date: April 2014
• Est. completion date: June 2015

Study information

• Verified date: July 2015
• Source: MedImmune LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is 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 subjects.

Description:

This is 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 subjects. Approximately 136 subjects will be entered to receive treatment across 5 fixed dose cohorts at 1 site. Investigational product will be delivered intravenously (IV) to 3 cohorts and intramuscularly (IM) to 2 cohorts. A total of 4 different dose levels of investigational product will be evaluated across the 5 cohorts. Subjects will be followed for approximately 1 year.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 342
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 49 Years

Eligibility

Key Inclusion Criteria:

• Age 18 through 49 years and in good health by history, physical exam, and labs

• Weight = 45 kg and = 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°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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Respiratory Syncytial Virus

Intervention

Drug:
• MEDI8897
Dose 1 - intramuscular (IM) delivery; Dose 2 - intravenous (IV) and intramuscular (IM) delivery; Dose 3 - intravenous (IV) delivery; Dose 4 - intravenous (IV) delivery
• Placebo
Solution containing no active ingredients

Locations

Country	Name	City	State
United States	Research Site	Overland Park	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
MedImmune LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Anti-RSV neutralization concentrations in serum		360 days	No
Other	Anti-RSV neutralization concentrations in nasal wash		180 days	No
Other	Assessment of RSV neutralizing activity of MEDI8897		180 days	No
Other	Assessment of MEDI8897 concentrations in nasal wash		180 days	No
Primary	Safety and tolerability of MEDI8897	Occurrence of adverse events, serious adverse events, adverse events of special interest, and new onset chronic disease.	360 days	Yes
Primary	Safety and tolerability of MEDI8897	Clinical laboratory assessments (ie, serum chemistry, hematology, and urinalysis)	90 days	Yes
Secondary	Pharmacokinetics of MEDI8897 in serum: terminal-phase elimination (t½)	This variable will be estimated for MEDI8897 in the IV and IM cohorts where the data allow.	360 days	No
Secondary	Pharmacokinetics of MEDI8897 in serum: systemic clearance (CL)	This variable will be estimated for MEDI8897 in the IV cohorts where the data allow.	360 days	No
Secondary	Pharmacokinetics of MEDI8897 in serum: extravascular systemic clearance (CL/F)	This variable will be estimated for MEDI8897 in the IM cohorts where the data allow.	360 days	No
Secondary	Pharmacokinetics of MEDI8897 in serum: bioavailability (F)	This variable will be estimated for MEDI8897 in the IM cohorts where the data allow.	360 days	No
Secondary	Incidence of anti-drug antibody to MEDI8897 in serum		360 days	No