Phase 1b Study of MK-1654 Safety and PK in Pre-Term and Full-Term Infants
- Conditions
- ower respiratory tract infections (LRI) caused by respiratory syncytial virus (RSV) A and B strainsMedDRA version: 20.0Level: LLTClassification code 10039247Term: RSV infectionSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2017-005062-21-ES
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 180
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the safety and tolerability of MK-1654 through Day 365;Secondary Objective: 1. To estimate the serum pharmacokinetic (PK) profile of MK-1654 on Days 7, 30, 90, 150, and 365<br>2. To describe the incidence of anti-drug antibodies (ADAs) to MK-1654 on Days 30, 90, 150, and 365;Primary end point(s): - Proportion of participants experiencing adverse events (AEs) through Day 14<br>- Proportion of participants experiencing serious adverse events (SAEs) through Day 365;Timepoint(s) of evaluation of this end point: There is an interim analysis planned to evaluate PK and safety data once Panels A-C complete their day 150 visit
- Secondary Outcome Measures
Name Time Method Secondary end point(s): The MK-1654 PK variable(s) AUC0-inf, Cmax, Tmax, t1/2, C7days, C30days, C90days, C150days and C365days;Timepoint(s) of evaluation of this end point: The serum pharmacokinetic (PK) profile of MK-1654 on Days 7, 30, 90, 150, and 365