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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: Completed Phase 1 study, sponsored by MedImmune.
NCT02290340 is a Phase 1 study that has completed, run by MedImmune. The registered enrollment target is 151 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (152% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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/
Interventions
- DRUG Placebo
- DRUG MEDI8897 10 mg
- DRUG MEDI8897 25 mg
- DRUG MEDI8897 50 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 151 participants |
| Start Date | 2015-01-13 |
| Est. Completion | 2016-09-28 |
| Phase | Phase 1 |
What the finished NCT02290340 record still lists
NCT02290340 is an interventional study that assigns participants to a tested intervention. The registered 151 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (152% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT02290340 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02290340's enrollment target sits among peer trials
151 363rd of 2000 higher than 1,638 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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