A Phase 1b/2a Randomized, Double-Blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in Healthy Preterm Infants

NCT02290340 | Completed Phase 1 Results

• 1 other identifier: D5290C00002
• Study Type: interventional
• Target: 151
• Locations: 3 countries
• Sites: 13

Brief 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 preterm infants.

Conditions

Respiratory Syncytial Virus

Keywords

Respiratory Syncytial Virus, RSV

Outcome Measures

Primary Outcomes (3)

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

  An adverse event (AE) is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening situation (immediate risk of dying); persistent or significant disability/incapacity of a participant who received MEDI8897. TEAEs and TESAEs were the events that occurred between administration of study drug (Day 1) and Day 361 that were absent before treatment or that worsened relative to pre-treatment state.

  From Study Drug Administration (Day 1) Through the Follow-up Period (Day 361)

• Number of Participants With Treatment-Emergent Adverse Events of Special Interest

  An AESI was one of scientific and medical interest specific to understanding of study product and may have required close monitoring and rapid communication by investigator (that is, within 24 hrs of knowledge of the event) to the sponsor. The AESIs for this study were hepatic function abnormality meeting the definition of Hy's law, hypersensitivity reactions including anaphylaxis, immune complex disease, and thrombocytopenia. Treatment-emergent AESIs were collected from the time of dosing until Day 361 post-dose.

  From Study Drug Administration (Day 1) Through the Follow-up Period (Day 361)

• Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events

  Laboratory abnormalities determined by the investigator to be clinically significant that occurred after study drug dosing through 151 days post-dose that were absent before treatment or that worsened relative to pre-treatment state were reported as TEAEs. Laboratory evaluations (haematology and serum chemistry) of blood samples were performed.

  From Study Drug Administration (Day 1) Through the Follow-up Period (Day 151)

Secondary Outcomes (8)

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

  Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose

• Maximum Observed Serum Concentration (Cmax) of MEDI8897

  Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose

• Area Under the Concentration-Time Curve From Day 1 to Day 151 (AUC [1-151]) of MEDI8897

  Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), and 150 (± 7) Post-dose

• Area Under the Concentration-Time Curve From Zero to Infinity (AUC [0-infinity]) of MEDI8897

  Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose

• Terminal Elimination Half Life (t1/2) of MEDI8897

  Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Participants will receive placebo intramuscularly.

Drug: Placebo

MEDI8897 10 mg

EXPERIMENTAL

Participants will receive a single dose of MEDI8897 10 milligram (mg) intramuscularly.

Drug: MEDI8897 10 mg

MEDI8897 25 mg

EXPERIMENTAL

Participants will receive a single dose of MEDI8897 25 mg intramuscularly.

Drug: MEDI8897 25 mg

MEDI8897 50 mg

EXPERIMENTAL

Participants will receive a single dose of MEDI8897 50 mg intramuscularly.

Drug: MEDI8897 50 mg

Interventions

Placebo DRUG

Participants will receive placebo intramuscularly.

Placebo

MEDI8897 10 mg DRUG

Participants will receive a single dose of MEDI8897 10 milligram (mg) intramuscularly.

MEDI8897 10 mg

MEDI8897 25 mg DRUG

Participants will receive a single dose of MEDI8897 25 mg intramuscularly.

MEDI8897 25 mg

MEDI8897 50 mg DRUG

Participants will receive a single dose of MEDI8897 50 mg intramuscularly.

MEDI8897 50 mg

Eligibility Criteria

• Age: Up to 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy infants born between 32 weeks 0 days and 34 weeks 6 days gestational age
• Infants who are entering their first RSV season at the time of screening

You may not qualify if:

• Gestational age \< 32 weeks 0 days and \>34 weeks 6 days
• Meets AAP or other local criteria to receive commercial palivizumab
• Any fever (≥ 100.4°F \[≥ 38.0°C\], regardless of route) or lower respiratory illness within 7 days prior to randomization
• Acute illness (defined as the presence of moderate or severe signs and symptoms) at the time of randomization
• Active RSV infection (a child with signs/symptoms of respiratory infection must have negative RSV testing) or known prior history of RSV infection
• Receipt of palivizumab or any RSV vaccine, including maternal RSV vaccination

Sponsors & Collaborators

• MedImmune LLC: lead

Study Sites (13)

Research Site

Anaheim, California, United States

Location

Research Site

Ontario, California, United States

Location

Research Site

Syracuse, New York, United States

Location

Research Site

Cleveland, Ohio, United States

Location

Research Site

Charleston, South Carolina, United States

Location

Research Site

St. George, Utah, United States

Location

Research Site

Marshfield, Wisconsin, United States

Location

Research Site

Santiago, Chile

Location

Research Site

Valdivia, Chile

Location

Research Site

Cape Town, South Africa

Location

Research Site

East London, South Africa

Location

Research Site

Johannesburg, South Africa

Location

Research Site

Pretoria, South Africa

Location

Results Point of Contact

• Title: M. Pamela Griffin
• Organization: MedImmune, LLC

information.center@astrazeneca.com

301-398-4095

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: October 17, 2014
• First Posted: November 14, 2014
• Study Start: January 13, 2015
• Primary Completion: September 28, 2016
• Study Completion: September 28, 2016
• Last Updated: September 19, 2018
• Results First Posted: September 19, 2018

Record last verified: 2018-09

Locations

US (7); CL (2); ZA (4)