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Respiratory Tract InfectionPhase 1/2NCT03524118

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

A Phase 1/2 study testing Clesrovimab in people with Respiratory Tract Infection and Respiratory Syncytial Virus, run by Merck Sharp & Dohme LLC at 34 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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 clesrovimab in healthy pre-term (born at 29 to 35 weeks gestational age) and full-term (born at >35 weeks gestational age) infants. Read more about this study

Who is it for?
Ages 2 weeks to 8 monthsHealthy volunteers can take part
What is being tested?
Clesrovimab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
183 participants
Where
34 sitesin 6 countries
Study dates
20 Sep 2018to 14 Sep 2022
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 weeks to 8 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

  • has been recommended to receive palivizumab per local standard of care
  • has ≥1 documented out-of-range safety laboratory results (adjusted for age) at the time of screening
  • 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
Show all 27Show fewer
  • 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

Trial locations and contacts

34 sites in 6 countries.

34 sites in 6 countries

United States17 sites

  • Children's Hospital - Colorado ( Site 0067)

    Aurora, Colorado, 80045

  • Coastal Pediatric Research ( Site 0028)

    Charleston, South Carolina, 29414

  • Cincinnati Children's Hospital Medical Center ( Site 0031)

    Cincinnati, Ohio, 45229

  • Ohio Pediatric Research Association ( Site 0066)

    Dayton, Ohio, 45414

  • University of Texas Medical Branch at Galveston ( Site 0039)

    Galveston, Texas, 77555

  • Tribe Clinical Research, LLC ( Site 0082)

    Greenville, South Carolina, 29607

  • Next Phase Research Alliance, LLC ( Site 0075)

    Homestead, Florida, 33030

  • Kapiolani Medical Center for Women and Children ( Site 0027)

    Honolulu, Hawaii, 96826

  • Children's Mercy Hospital ( Site 0037)

    Kansas City, Missouri, 64108

  • Dartmouth-Hitchcock Medical Center ( Site 0032)

    Lebanon, New Hampshire, 03766

  • University of Wisconsin American Family Children's Hospital ( Site 0068)

    Madison, Wisconsin, 53792

  • Acevedo Clinical Research Associates ( Site 0025)

    Miami, Florida, 33142

  • WakeMed Health and Hospitals ( Site 0033)

    Raleigh, North Carolina, 27610

  • Tekton Research, Inc. ( Site 0026)

    San Antonio, Texas, 78240

  • SUNY Upstate Medical University Hospital ( Site 0029)

    Syracuse, New York, 13210

  • Multicare Institute For Research And Innovation ( Site 0035)

    Tacoma, Washington, 98405

  • Cotton-O'Neil Clinical Research Center PediatricCare ( Site 0081)

    Topeka, Kansas, 66604

Other trials in United States

Colombia6 sites

  • MedPlus Medicina Prepagada S.A. ( Site 0095)

    Bogotá, Bogota D.C., 110221

  • Fundacion Universitaria de Ciencias de la Salud - Sociedad de Cirugia ( Site 0099)

    Bogotá, Bogota D.C., 111411

  • Fundacion Valle del Lili ( Site 0090)

    Cali, Valle del Cauca Department, 760032

  • Centro de Atención e Investigación Médica SAS - CAIMED CHIA ( Site 0100)

    Chía, Cundinamarca, 250001

  • Fundacion Hospital San Vicente de Paul ( Site 0097)

    Medellín, Antioquia, 050010

  • Universidad Pontificia Bolivariana - Clinica Universitaria Bolivariana ( Site 0098)

    Medellín, Antioquia, 050036

Other trials in Colombia

Chile4 sites

  • Centro de Investigacion Clinica Bradford Hill ( Site 0103)

    Santiago, Region M. de Santiago, 7650698

  • Hospital La Florida ( Site 0050)

    Santiago, Region M. de Santiago, 8242238

  • Facultad Medicina Universidad de Chile ( Site 0104)

    Santiago, Region M. de Santiago, 8380453

  • Hospital Padre Hurtado ( Site 0102)

    Santiago, Region M. de Santiago, 8880465

Other trials in Chile

South Korea3 sites

  • Seoul National University Hospital ( Site 0071)

    Seoul, 03080

  • Severance Hospital Yonsei University Health System ( Site 0073)

    Seoul, 03722

  • Samsung Medical Center ( Site 0072)

    Seoul, 06351

Other trials in South Korea

South Africa2 sites

  • Tygerberg Hospital ( Site 0261)

    Cape Town, Western Cape, 7505

  • Chris Hani Baragwanath Academic Hospital ( Site 0262)

    Johannesburg, Gauteng, 2013

Other trials in South Africa

Spain2 sites

  • Hospital Universitario La Paz ( Site 0242)

    Madrid, 28046

  • Hospital Clinico Universitario de Santiago ( Site 0241)

    Santiago de Compostela, La Coruna, 15706

Other trials in Spain

About this study

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

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and incidence of anti-drug antibodies (ADAs) of single ascending doses of clesrovimab in healthy pre-term (born at 29 to 35 weeks gestational age) and full-term (born at >35 weeks gestational age) infants. Participants will be randomized into 1 of 4 dose escalation panels (Panels A to D); an additional panel (Panel E) of full-term infants will receive the same dose as Panel D. Key safety and tolerability variables will be reviewed after each dose panel prior to administering the next-highest dose.

Read the detailed description

Participants in Dose Panels A, B, C, D1, and E1 will be followed for up to 365 days. After protocol Amendment 4 (AM4), participants in Dose Panels D2 and E2 will be followed for up to 545 days.

Being tested
Clesrovimab, Placebo
Medical subject headings
Respiratory Tract Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ClesrovimabDrug

    Also called MK-1654

    Single ascending doses of clesrovimab will be administered via IM injection.

  • PlaceboDrug

    Placebo (0.9% sodium chloride [NaCl]) will be administered via IM injection.

Study groups in NCT03524118
Study groupRoleWhat they receive
Panel A: Pre-term clesrovimab Dose 1ExperimentalPre-term infants will receive clesrovimab Dose 1 via intramuscular (IM) injection and will be followed for up to 365 days.
Receives: Drug: Clesrovimab
Panel B: Pre-term clesrovimab Dose 2ExperimentalPre-term infants will receive clesrovimab Dose 2 via IM injection and will be followed for up to 365 days.
Receives: Drug: Clesrovimab
Panel C: Pre-term clesrovimab Dose 3ExperimentalPre-term infants will receive clesrovimab Dose 3 via IM injection and will be followed for up to 365 days.
Receives: Drug: Clesrovimab
Panel D1: Pre-term clesrovimab Dose 4ExperimentalPre-term infants enrolled prior to AM4 will receive clesrovimab Dose 4 via IM injection and will be followed for up to 365 days.
Receives: Drug: Clesrovimab
Panel D2: Pre-term clesrovimab Dose 4ExperimentalPre-term infants enrolled after AM4 will receive clesrovimab Dose 4 via IM injection and will be followed for up to 545 days.
Receives: Drug: Clesrovimab
Panel E1: Full-term clesrovimab Dose 4ExperimentalFull-term infants enrolled prior to AM4 will receive clesrovimab Dose 4 via IM injection and will be followed for up to 365 days.
Receives: Drug: Clesrovimab
Panel E2: Full-term clesrovimab Dose 4ExperimentalFull-term infants enrolled after AM4 will receive clesrovimab Dose 4 via IM injection and will be followed for up to 545 days.
Receives: Drug: Clesrovimab
PlaceboPlacebo comparatorPre-term infants will receive placebo via IM injection.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Who Experienced At Least One Solicited Injection Site Adverse Event (AE)

    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 were monitored from Day 1 to Day 5.

    Measured: Up to Day 5

  2. Percentage of Participants Who Experienced At Least One Solicited Systemic Adverse Event (AE)

    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 were monitored from Day 1 to Day 5.

    Measured: Up to Day 5

  3. Percentage of Participants Who Experienced At Least One Serious Adverse Event (SAE)

    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.

    Measured: Up to Day 545

Secondary outcomes (10)

  1. Area Under the Serum-Concentration Time Curve From Zero to Infinity (AUC0-∞)

    AUC0-∞ is a measure of the extrapolated mean concentration in serum from dosing to infinity.

    Measured: At designated time points (up to 1 year post-dose)

  2. Maximum Serum Concentration (Cmax) of Clesrovimab

    Cmax is the highest observed serum drug concentration.

    Measured: At designated time points (up to 1 year post-dose)

  3. Time to Maximum Serum Concentration (Tmax) of Clesrovimab

    Tmax is the time taken to reach the maximum observed plasma (Cmax) concentration of Clesrovimab.

    Measured: At designated time points (up to 1 year post-dose)

  4. Apparent Terminal Half-life (t1/2) of Clesrovimab

    t1/2 is the time required for 50% of drug to be cleared from serum.

    Measured: At designated time points (up to 1 year post-dose)

  5. Serum Concentration of Clesrovimab on Day 7 (C7days)

    Serum concentration of clesrovimab was measured on Day 7.

    Measured: Day 7

  6. Serum Concentration of Clesrovimab on Day 14 (C14days)

    Serum concentration of clesrovimab was measured on Day 14.

    Measured: Day 14

  7. Serum Concentration of Clesrovimab on Day 90 (C90days)

    Serum concentration of clesrovimab was measured on Day 90.

    Measured: Day 90

  8. Serum Concentration of Clesrovimab on Day 150 (C150days)

    Serum concentration of clesrovimab was measured on Day 150.

    Measured: Day 150

  9. Serum Concentration of Clesrovimab on Day 365 (C365days)

    Serum concentration of clesrovimab was measured on Day 365.

    Measured: Day 365

  10. Number of Participants With Positive Titer of Anti-Drug Antibodies (ADAs) for Clesrovimab: Panels A, B, C, D1, D2, E1, and E2

    ADA was assessed at 2 or 3 of the following timepoints for each participant: Days 14, 90, 150, 365 and 545. ADA status for each participant was determined across the timepoints assessed. The definitions of the categories are as follows: (1) ADA Negative: participants whose ADA results were negative at all timepoints measured; (2) Non-treatment emergent positive: participants whose ADA result was positive only at baseline or if postdose titer increased by less than 2-fold relative to the baseline titer; (3) Positive response to MK-1654: participants whose ADA result was negative at baseline and positive at one or more postdose timepoints or participants whose ADA result was positive at baseline and postdose titer increased by greater than or equal to 2-fold relative to the baseline titer.

    Measured: Days 14, 90, 150, 365 and 545

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 May 2018
  2. Study start20 Sep 2018
  3. Primary completion14 Sep 2022
  4. Study completion14 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Sequential
Model description
Single ascending dose
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
183 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03524118
Sponsor's protocol ID
1654-002
Other IDs
MK-1654-002, 2017-005062-21, 2017
Status last verified
Jan 2025
First submitted
11 May 2018
Last updated
14 Jan 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Publications

  • Madhi SA, Simoes EAF, Acevedo A, Novoa Pizarro JM, Shepard JS, Railkar RA, Cao X, Maas BM, Zang X, Krick A, Roadcap B, Vora KA, Aliprantis AO, Lee AW, Sinha A. A Phase 1b/2a Trial of a Half-life Extended Respiratory Syncytial Virus Neutralizing Antibody, Clesrovimab, in Healthy Preterm and Full-term Infants. J Infect Dis. 2025 Mar 17;231(3):e478-e487. doi: 10.1093/infdis/jiae581.

    PubMed 39601265

  • Thambi N, Phuah JY, Staupe RP, Tobias LM, Cao Y, McKelvey T, Railkar RA, Aliprantis AO, Arriola CS, Maas BM, Vora KA. Development of High-Titer Antidrug Antibodies in a Phase 1b/2a Infant Clesrovimab Trial Are Associated With RSV Exposure Beyond Day 150. J Infect Dis. 2025 Mar 17;231(3):e488-e496. doi: 10.1093/infdis/jiae582.

    PubMed 39590882

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Clesrovimab in people with Respiratory Tract Infection and Respiratory Syncytial Virus, run by Merck Sharp & Dohme LLC at 34 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in United States, Colombia, Chile, South Korea, South Africa and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Who Experienced At Least One Solicited Injection Site Adverse Event (AE) (time frame: Up to Day 5). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03524118, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2025.

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