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Completed

NCT Number: NCT02114268

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

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.

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Key information

Conditions

Respiratory Syncytial Virus Infections Infections Mononegavirales Infections Paramyxoviridae Infections Pneumovirus Infections RNA Virus Infections Virus Diseases

Age range

18 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Overland Park, Kansas, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MEDI8897 Intravenous

Drug

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

Placebo

Drug

Participants received placebo on Day 1.

MEDI8897 Intramuscular

Drug

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

Primary outcomes

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

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

    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 outcomes

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

    Time frame: 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

    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).

  2. Maximum Observed Serum Concentration (Cmax) for MEDI8897

    Time frame: 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

    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).

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

    Time frame: 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

    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).

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

    Time frame: 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

    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).

  5. Systemic Clearance (CL) for MEDI8897

    Time frame: 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) 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).

  6. Volume of Distribution (Vz) for MEDI8897

    Time frame: 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

    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).

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

    Time frame: Predose and Day 15, 31, 91, 181, 271 and 361

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

Sponsors and collaborators

Lead sponsor

MedImmune LLC

Industry

Registry information

Official study title

A Phase 1, Randomized, Double-blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI8897 in Healthy Adults

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 15, 2014
Registry last updated
Nov 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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