NL-OMON42680撤回不适用
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 - JNJ-53718678 in infants hospitalized with RSV infection
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 5
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 11（—）
入选标准
- •1. Each subject*s legally acceptable representative (ie, parent(s)/legal guardian/caregiver)
- •must sign an 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 (see Section 4.3) and study procedures.
- •2. Subject has presented at the hospital for suspected RSV infection within 72 hours prior
- •to screening completion (ie, randomization).
- •3. Subject has been hospitalized for this suspected RSV infection.
- •4. Subject is a boy or a girl, who is >1 month to *24 months of age on the day of
- •randomization.
- •5. Subject has been diagnosed with RSV infection using a polymerase chain reaction
- •(PCR)-based assay, preferably commercially available locally.
- •Note: in case there is no commercially available PCR-based assay at the site, the
- •Sponsor should be consulted for agreement on the assay to be used.
- •6. Subject was born after a normal term pregnancy (*37 weeks and 0 days).
- •7. With the exception of the RSV-related illness, subject is otherwise in good health
- •without any significant medical illness on the basis of a medical evaluation that reveals
- •the absence of any clinically relevant abnormality and includes a physical examination,
- •skin examination, medical history, vital signs, ECG, and the results of blood
- •biochemistry, blood coagulation, and hematology tests performed at Screening. If there
- •are abnormalities, the subject may be included only if the Investigator judges the
- •abnormalities or deviations from normal to be not clinically significant. This
- •determination must be recorded in the subject*s source documents and initialed by the
- •Investigator.
- •Note: Procedures that are standard of care and performed within 72 hours prior to
- •screening completion (ie, randomization) may be used in determining study eligibility.
排除标准
- •1. Subject is upon current admission initially hospitalized in the ICU and/or in need of
- •invasive endotracheal mechanical ventilation.
- •2. Subject has a history of any illness or a concurrent illness that, in the opinion of the
- •Investigator, might confound the results of the study or pose an additional risk in
- •administering study drug to the subject or that could prevent, limit or confound the
- •protocol-specified assessments. This may include, but is not limited to, bacteremia,
- •gross abnormalities, organ dysfunction, or severe comorbidity.
- •Note: The use of intravenous fluids is not exclusionary as long as the Investigator
- •believes the patient*s gastrointestinal tract still functions properly (i.e., is able to absorb
- •drugs or nutrition).
- •3. Subjects who had major surgery within the 28 days prior to randomization or planned
- •major surgery through the course of the study.
- •4. Subject has major congenital anomalies (eg, AV shunt) or known cytogenetic disorders
- •(eg, Down*s syndrome).
- •Note: Open ductus arteriosus and open foramen ovale are not exclusionary as not
- •considered major anomalies.
- •5. Subject has known or suspected immunodeficiency, such as known human
- •immunodeficiency virus (HIV) infection.
- •6. Subject has known or suspected hepatitis B or C infection.
- •7. Subject has known allergies, hypersensitivity, or intolerance to JNJ-53718678 or its
- •excipients.
研究者
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