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

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ClinicalTrials.gov Identifier: NCT03524118
Recruitment Status : Recruiting
First Posted : May 14, 2018
Last Update Posted : December 6, 2019
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Respiratory Tract Infection Respiratory Syncytial Virus Drug: MK-1654 Drug: Placebo Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Single ascending dose
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : September 20, 2018
Estimated Primary Completion Date : April 11, 2022
Estimated Study Completion Date : April 11, 2022

Arm Intervention/treatment
Experimental: Panel A: Pre-term MK-1654 Dose 1
Pre-term infants will receive MK-1654 Dose 1 via intramuscular (IM) injection.
Drug: MK-1654
Single ascending doses of MK-1654 will be administered via IM injection.

Experimental: Panel B: Pre-term MK-1654 Dose 2
Pre-term infants will receive MK-1654 Dose 2 via IM injection.
Drug: MK-1654
Single ascending doses of MK-1654 will be administered via IM injection.

Experimental: Panel C: Pre-term MK-1654 Dose 3
Pre-term infants will receive MK-1654 Dose 3 via IM injection.
Drug: MK-1654
Single ascending doses of MK-1654 will be administered via IM injection.

Experimental: Panel D: Pre-term MK-1654 Dose 4
Pre-term infants will receive MK-1654 Dose 4 via IM injection.
Drug: MK-1654
Single ascending doses of MK-1654 will be administered via IM injection.

Experimental: Panel E: Full-term MK-1654 Dose 4
Full-term infants will receive MK-1654 Dose 4 via IM injection.
Drug: MK-1654
Single ascending doses of MK-1654 will be administered via IM injection.

Placebo Comparator: Placebo
Pre-term infants will receive placebo via IM injection.
Drug: Placebo
Placebo (0.9% sodium chloride [NaCl]) will be administered via IM injection.




Primary Outcome Measures :
  1. Percentage of participants experiencing a solicited injection site adverse event (AE) [ Time Frame: Up to Day 5 ]
    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection site AEs will be monitored from Day 1 to Day 5.

  2. Percentage of participants experiencing a solicited systemic AE [ Time Frame: Up to Day 5 ]
    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs will be monitored from Day 1 to Day 5.

  3. Percentage of participants experiencing a serious AE (SAE) [ Time Frame: Up to 1 year ]
    An SAE is any untoward medical occurrence that, at any dose, results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant injury/incapacity; is a congenital anomaly/birth defect; or is an other important medical event.


Secondary Outcome Measures :
  1. Area under the plasma-concentration time curve from zero to infinity (AUC0-∞) [ Time Frame: At designated time points (up to 1 year post-dose) ]
    AUC0-∞ is a measure of the extrapolated mean concentration in plasma from dosing to infinity.

  2. Maximum plasma concentration (Cmax) of MK-1654 [ Time Frame: At designated time points (up to 1 year post-dose) ]
    Cmax is the highest observed plasma drug concentration.

  3. Time to maximum plasma concentration (Tmax) of MK-1654 [ Time Frame: At designated time points (up to 1 year post-dose) ]
    Tmax is the amount of time required to reach Cmax.

  4. Apparent terminal half-life (t1/2) of MK-1654 [ Time Frame: At designated time points (up to 1 year post-dose) ]
    t1/2 is the time required for 50% of drug to be cleared from plasma.

  5. Plasma concentration of MK-1654 on Day 7 (C7days) [ Time Frame: Day 7 ]
    Plasma concentration of MK-1654 will be measured on Day 7.

  6. Plasma concentration of MK-1654 on Day 14 (C14days) [ Time Frame: Day 14 ]
    Plasma concentration of MK-1654 will be measured on Day 14.

  7. Plasma concentration of MK-1654 on Day 90 (C90days) [ Time Frame: Day 90 ]
    Plasma concentration of MK-1654 will be measured on Day 90.

  8. Plasma concentration of MK-1654 on Day 150 (C150days) [ Time Frame: Day 150 ]
    Plasma concentration of MK-1654 will be measured on Day 150.

  9. Plasma concentration of MK-1654 on Day 365 (C365days) [ Time Frame: Day 365 ]
    Plasma concentration of MK-1654 will be measured on Day 365.

  10. Titer of ADAs to MK-1654 on Day 14 [ Time Frame: Day 14 ]
    Titers of ADAs to MK-1654 will be measured on Day 14.

  11. Titer of ADAs to MK-1654 on Day 90 [ Time Frame: Day 90 ]
    Titers of ADAs to MK-1654 will be measured on Day 90.

  12. Titer of ADAs to MK-1654 on Day 150 [ Time Frame: Day 150 ]
    Titers of ADAs to MK-1654 will be measured on Day 150.

  13. Titer of ADAs to MK-1654 on Day 365 [ Time Frame: Day 365 ]
    Titers of ADAs to MK-1654 will be measured on Day 365.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 8 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03524118


Contacts
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Contact: Toll Free Number 1-888-577-8839 Trialsites@merck.com

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Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Medical Director Merck Sharp & Dohme Corp.

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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT03524118     History of Changes
Other Study ID Numbers: 1654-002
MK-1654-002 ( Other Identifier: Merck Protocol Number )
2017-005062-21 ( EudraCT Number )
First Posted: May 14, 2018    Key Record Dates
Last Update Posted: December 6, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Tract Infections
Infection
Respiratory Tract Diseases