NL-OMON43180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<br>
Janssen Science Ireland UC0 个研究点目标入组 3 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 3
研究概览
简要总结
Trial never started
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 initiated 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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