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

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

MEDI8897 Intravenous

Placebo

MEDI8897 Intravenous

MEDI8897 Intramuscular

About this trial

This is an interventional prevention trial for Respiratory Syncytial Virus Infections focused on measuring Respiratory Syncytial Virus, RSV

Eligibility Criteria

18 Years - 49 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Research Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Placebo Comparator

Arm Label

MEDI8897 300 milligram (mg) Intravenous (IV)

MEDI8897 1000 mg IV

MEDI8897 3000 mg IV

MEDI8897 100 mg Intramuscular (IM)

MEDI8897 300 mg IM

Placebo

Arm Description

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

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

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

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

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

Participants received placebo on Day 1.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

The Tmax is defined as actual sampling time to reach maximum observed MEDI8897 concentration. The reported Standard Deviation values are actually Relative Standard Deviation (RSD) values (that is, Coefficient of Variation).

Maximum Observed Serum Concentration (Cmax) for MEDI8897

The Cmax is the maximum observed serum concentration of MEDI8897. The reported Standard Deviation values are actually Relative Standard Deviation (RSD) values (that is, Coefficient of Variation).

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

The AUC (0-infinity) is the area under the serum concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the serum concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant. The reported Standard Deviation values are actually Relative Standard Deviation (RSD) values (that is, Coefficient of Variation).

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

The terminal elimination half-life (t1/2) is the time measured for the serum concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z). Here 'n' signifies participants evaluable for specified categories, for each arm, respectively. The reported Standard Deviation values are actually Relative Standard Deviation (RSD) values (that is, Coefficient of Variation).

Systemic Clearance (CL) for MEDI8897

Systemic Clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the body. The total systemic clearance after the dose was estimated by dividing the total administered dose by the Area Under the Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]). Apparent clearance (CL/F) for the IM dose groups. The reported Standard Deviation values are actually Relative Standard Deviation (RSD) values (that is, Coefficient of Variation).

Volume of Distribution (Vz) for MEDI8897

The Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a study drug. Apparent volume of distribution (Vz/F) for the IM dose groups. The reported Standard Deviation values are actually Relative Standard Deviation (RSD) values (that is, Coefficient of Variation).

Number of Participants With Positive Anti-Drug Antibody (ADA)

Participants were tested for anti-drug antibody to MEDI8897 prior to enrollment, predose and postdose.

Full Information

NCT ID

NCT02114268

First Posted

April 3, 2014

Last Updated

October 5, 2016

Sponsor

MedImmune LLC

1. Study Identification

Unique Protocol Identification Number

NCT02114268

Brief Title

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

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Completed

Study Start Date

April 2014 (undefined)

Primary Completion Date

June 2015 (Actual)

Study Completion Date

June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

MedImmune LLC

4. Oversight

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Respiratory Syncytial Virus Infections

Keywords

Respiratory Syncytial Virus, RSV

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

342 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MEDI8897 300 milligram (mg) Intravenous (IV)

Arm Type

Experimental

Arm Description

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

Arm Title

MEDI8897 1000 mg IV

Arm Type

Experimental

Arm Description

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

Arm Title

MEDI8897 3000 mg IV

Arm Type

Experimental

Arm Description

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

Arm Title

MEDI8897 100 mg Intramuscular (IM)

Arm Type

Experimental

Arm Description

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

Arm Title

MEDI8897 300 mg IM

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Participants received placebo on Day 1.

Intervention Type

Drug

Intervention Name(s)

MEDI8897 Intravenous

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Participants received placebo on Day 1.

Intervention Type

Drug

Intervention Name(s)

MEDI8897 Intravenous

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

MEDI8897 Intravenous

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

MEDI8897 Intramuscular

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

MEDI8897 Intramuscular

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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.

Time Frame

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

Secondary Outcome Measure Information:

Title

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

Description

The Tmax is defined as actual sampling time to reach maximum observed MEDI8897 concentration. The reported Standard Deviation values are actually Relative Standard Deviation (RSD) values (that is, Coefficient of Variation).

Time Frame