A Phase 1b, randomized, partially double-blind, placebo-controlled study to assess the pharmacokinetics, safety, and tolerability of multiple doses of orally administered JNJ-53718678 in infants hospitalized with RSV infection

Janssen Sciences Ireland UC0 个研究点目标入组 42 人开始时间: 2015年9月7日最近更新: 2018年5月21日

适应症

试验速览

暂无简介。

•- Participant has presented at the hospital for suspected Respiratory Syncytial Virus (RSV) infection within 72 hours prior to Screening completion
•- Participant has been hospitalized for this suspected RSV infection
•- Participant has been diagnosed with RSV infection using a polymerase chain reaction (PCR)- based assay, preferably commercially available locally
•- Participant was born after a normal term pregnancy (greater than or equal to 37 weeks and 0 days)
•- A legally acceptable representative of the participant must sign an Informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study, are willing for their child to participate in the study, are willing for their child to remain in the hospital for the first 3 days of dosing (even if not clinically indicated), and are willing/able to adhere to the prohibitions and restrictions specified in the protocol and study procedures
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 42
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- Participant who had major surgery within the 28 days prior to randomization or planned major surgery through the course of the study
•- Participant has major congenital anomalies or known cytogenetic disorders
•- Participant has known or suspected immunodeficiency, such as known human immunodeficiency virus (HIV) infection
•- Participant has known or suspected hepatitis B or C infection
•- Participant is upon current admission initially hospitalized in the Intensive care unit (ICU) and/or in need of invasive endotracheal mechanical ventilation

发起方