ニルセビマブ2回投与後の安全性、薬物動態、抗薬物抗体および抗RSV抗体を評価する研究

基本情報

NCT ID

NCT06042049

ステータス

実施中（募集終了）

試験のフェーズ

第3相

試験タイプ

介入

目標被験者数

33

治験依頼者名

AstraZeneca

概要

The purpose of this study is to measure the safety, PK, occurrence of ADA to nirsevimab, and anti-RSV neutralizing Ab in Japanese children with certain health conditions or pre-term infants aged ≤12 months. Study details include * The study duration is approximately 21 months with a 2-month enrollment period. * Study intervention is 2 doses administered 5- 6 months apart. * The study has 5 or 6 site visits and several telephone contacts with a 2 or 4 week interval.

対象疾患

介入

依頼者（Sponsor）