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NCT02290340 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by MedImmune.

Completed
Registry status
Phase 1
Development phase
151
Enrollment target

NCT02290340 is a Phase 1 study that has completed, run by MedImmune. The registered enrollment target is 151 participants.

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The verdict

NCT02290340, a Phase 1 study, has completed, sponsored by MedImmune.

COMPLETED
Registry status
Phase 1
Development phase
151 participants
Enrollment target

Study 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.

Interventions

  • DRUG Placebo
  • DRUG MEDI8897 10 mg
  • DRUG MEDI8897 25 mg
  • DRUG MEDI8897 50 mg

Trial Details

FieldValue
Enrollment Target 151 participants
Start Date 2015-01-13
Est. Completion 2016-09-28
Phase Phase 1

Sponsor

MedImmune

210 total trials

What the Registry Record Tells You About NCT02290340

The ClinicalTrials.gov registry entry for NCT02290340 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 151 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is MedImmune, which has 210 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.

NCT02290340 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02290340 about?

NCT02290340 is a clinical study titled "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". 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.

What is the current status of trial NCT02290340?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 151 participants. The study started on 2015-01-13. Estimated completion is 2016-09-28.

What interventions are being tested in trial NCT02290340?

The interventions under investigation include: Placebo (DRUG), MEDI8897 10 mg (DRUG), MEDI8897 25 mg (DRUG), MEDI8897 50 mg (DRUG).

Who is sponsoring clinical trial NCT02290340?

This trial is sponsored by MedImmune, which has 210 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.