Safety, Tolerability, and Pharmacokinetics of MK-1654 in Infants (MK-1654-002)



Status:Recruiting
Conditions:Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:Any
Updated:3/29/2019
Start Date:September 20, 2018
End Date:April 12, 2021
Contact:Toll Free Number
Email:Trialsites@merck.com
Phone:1-888-577-8839

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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

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and
incidence of anti-drug antibodies (ADAs) of single ascending doses of MK-1654 in healthy
pre-term (born at 29 to 35 weeks gestational age) and full-term (born at >35 weeks
gestational age) infants. Key safety and tolerability variables will be reviewed after each
panel prior to administering the next-highest dose.


Inclusion Criteria:

- is healthy, based on screening safety laboratory, medical history, and physical
examination results

- 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

- weighs ≥2 kg at screening

Exclusion Criteria:

- has been recommended to receive palivizumab per local standard of care

- has ≥1 documented out-of-range safety laboratory results (adjusted for age)

- has a known hypersensitivity to any component of the respiratory syncytial virus (RSV)
monoclonal antibody

- has a history of congenital or acquired immunodeficiency (e.g., splenomegaly)

- has documented human immunodeficiency virus (HIV) infection, hepatitis B (HBsAg
positive), or hepatitis C (HCV ribonucleic acid [RNA] positive)

- has known history of functional or anatomic asplenia

- has a diagnosis of failure to thrive within 14 days of screening

- has known or history of a coagulation disorder contraindicating intramuscular
injection

- has received or is expected to receive blood products (except irradiated platelets)
within 3 months prior to enrollment

- has prior known documented RSV infection

- has hemodynamically significant congenital heart disease

- has chronic lung disease of prematurity requiring ongoing medical therapy

- 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

- has any history of malignancy prior to randomization

- if any of the following apply, the Day 1 visit may be rescheduled for a time when
these criteria are not met:

- 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

- is not up-to-date on required vaccinations per local pediatric vaccine schedule at
time of screening

- has received inactivated or component vaccines (eg, influenza, hepatitis B) less than
14 days pre-dose

- has received live, attenuated, non-study licensed pediatric vaccines (e.g., Bacillus
Calmette-Guerin vaccine) less than 30 days pre-dose

- has received any prior vaccine or monoclonal antibody (mAb) for the prevention of RSV

- 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)

- has enrolled previously in this study and been discontinued

- participant's mother participated in a RSV vaccine clinical study while pregnant and
participant is ≤3 months of chronological age

- is unable to provide blood sample at screening

- cannot be adequately followed for safety according to the protocol plan

- has a parent/legally acceptable representative who is unlikely to adhere to study
procedures, keep appointments, or is planning to relocate during the study

- is, or has, an immediate family member (eg, spouse, parent/guardian, sibling, or
child) who is directly involved with the study at the site or with the Sponsor
We found this trial at
16
sites
1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Phone: 603-653-6070
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Phone: 513-636-4463
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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Cincinnati, OH
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2401 Gillham Rd
Kansas City, Missouri 64108
(816) 234-3000
Phone: 816-302-8384
Children's Mercy Hospital Children's Mercy Hospitals and Clinics continues redefining pediatric medicine throughout the Midwest...
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Kansas City, MO
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750 E Adams St
Syracuse, New York 13210
(315) 464-5540
Phone: 315-706-5636
SUNY Upstate Medical University Hospital SUNY Upstate Medical University in Syracuse, NY, is the only...
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Syracuse, NY
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13123 E 16th Ave
Aurora, Colorado 80045
(720) 777-1234
Phone: 720-777-4163
Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
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Charleston, South Carolina 29414
Phone: 843-284-4677
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Dayton, Ohio 45414
Phone: 937-424-9294
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Galveston, Texas
Phone: 409-772-1696
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Homestead, Florida 33030
Phone: 305-615-9697
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1319 Punahou St
Honolulu, Hawaii 96826
(808) 983-6000
Phone: 808-369-1247
Kapiolani Medical Center for Women and Children Hawai‘i Pacific Health is an integrated health care...
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Madison, Wisconsin 53705
Phone: 608-263-8558
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Miami, Florida 33142
Phone: 786-212-4187
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Raleigh, North Carolina 27610
Phone: 919-350-5585
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4534 West Gate Boulevard
San Antonio, Texas 78240
Phone: 210-996-2600
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Santiago,
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Tacoma, Washington 98405
Phone: 253-403-0366
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