EUCTR2017-005062-21-ES进行中（未招募）1 期
A Double-blind, Randomized, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MK 1654 in Pre-Term and Full-Term Infants
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 180
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Be healthy (based on screening safety laboratory, medical history, and physical examination results) participants
- •2. Participant is Male or Female
- •3. Participant is a pre-term infant (born at 29 weeks to 35 weeks gestational age [inclusive]) or a full-term infant (born at over 35 weeks gestational age), as confirmed in medical records, at the time of signing the informed consent.
- •4. Participant has chronological age between 2 weeks and 8 months (inclusive) at the time of signing the informed consent
- •5. Participant weighs at least 2 kg at the time of screening
- •6. The participant’s legally acceptable representative provides written informed consent for the study. The participant’s legally acceptable representative may also provide consent for Future Biomedical Research. However, the participant may participate in the main study without participating in Future Biomedical Research
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 180
- •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
排除标准
- •1. Has been recommended to receive palivizumab per local standard of care
- •2. Has one or more out-of-range safety laboratory results:
- •a. Serum Cr >1.5 x upper limit of normal (ULN) for age
- •b. AST/ALT >1.5 X ULN
- •c. Hb <9.5 g/dL
- •d. WBC <4000 cells/mm3
- •e. Platelets <120,000 mm3
- •3. Has a known hypersensitivity to any component of the RSV monoclonal antibody
- •4. Has a history of congenital or acquired immunodeficiency (eg, splenomegaly)
- •5. Mother has documented human immunodeficiency virus (HIV) infection and HIV infection in the infant cannot be ruled out
- •6. Mother has documented hepatitis B infection (HBsAg+) or hepatitis C (HCV Ab+) and hepatitis B or hepatitis C infection in the infant cannot be ruled out
- •7. Has known or history of functional or anatomic asplenia
- •8. Has a recent (within 14 days prior to screening) diagnosis of failure to thrive
- •9. Has known or history of a coagulation disorder contraindicating intramuscular injection
- •10. Has received a blood transfusion or blood products, including immunoglobulins
- •11. Has had prior known RSV infection
- •12. Has had congenital heart disease
- •13. Has had chronic lung disease of prematurity requiring ongoing medical therapy
- •14. Has a history or current evidence of any condition, therapy, lab abnormality or other circumstance that, in the opinion of the investigator, might expose the participant to undue risk by participating in the study, confound the results of the study, or interfere with the participant’s participation for the full duration of the study
- •15. Has any history of malignancy prior to randomization
- •16. Has had a recent febrile illness (rectal temperature 38.1°C [100.5°F] or higher or axillary temperature 37.8°C [100.0°F] or higher) within 72 hours pre-dose
- •17. Is not up-to-date on required vaccinations per local pediatric vaccine schedule at time of screening
- •18. Has received inactivated or component vaccines (eg, influenza, hepatitis B) less than 14 days pre-dose.
- •19. Has received live, non-study licensed pediatric vaccines less than 30 days pre-dose
- •20. Prior administration of any vaccine or monoclonal antibody (mAb) for the prevention of RSV
- •21. Is currently participating in or has participated in an interventional clinical study with an investigational compound or device at any time prior to first dose administration or while participating in this current study. Participants enrolled in observational studies may be included and will be reviewed on a case-by-case basis for approval by the Sponsor
- •22. Has enrolled previously in the current study and been discontinued
- •23. Is unable to provide blood sample at screening
- •24. Cannot be adequately followed for safety according to the protocol plan
- •25. Has a parent/legal guardian/legally acceptable representative who is unlikely to adhere to study procedures, keep appointments, or is planning to relocate during the study
- •26. Has any other reason that in the opinion of the investigator may interfere with the evaluation required by the study
- •27. Is or has an immediate family member (eg, spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this study
研究者
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