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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
183
Single ascending doses of clesrovimab will be administered via IM injection.
Placebo (0.9% sodium chloride \[NaCl\]) will be administered via IM injection.
Children's Hospital - Colorado ( Site 0067)
Aurora, Colorado, United States
Next Phase Research Alliance, LLC ( Site 0075)
Homestead, Florida, United States
Acevedo Clinical Research Associates ( Site 0025)
Miami, Florida, United States
Kapiolani Medical Center for Women and Children ( Site 0027)
Honolulu, Hawaii, United States
Cotton-O'Neil Clinical Research Center PediatricCare ( Site 0081)
Topeka, Kansas, United States
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.
Time frame: Up to Day 5
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.
Time frame: Up to Day 5
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.
Time frame: Up to Day 545
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.
Time frame: At designated time points (up to 1 year post-dose)
Maximum Serum Concentration (Cmax) of Clesrovimab
Cmax is the highest observed serum drug concentration.
Time frame: At designated time points (up to 1 year post-dose)
Time to Maximum Serum Concentration (Tmax) of Clesrovimab
Tmax is the time taken to reach the maximum observed plasma (Cmax) concentration of Clesrovimab.
Time frame: At designated time points (up to 1 year post-dose)
Apparent Terminal Half-life (t1/2) of Clesrovimab
t1/2 is the time required for 50% of drug to be cleared from serum.
Time frame: At designated time points (up to 1 year post-dose)
Serum Concentration of Clesrovimab on Day 7 (C7days)
Serum concentration of clesrovimab was measured on Day 7.
Time frame: Day 7
Serum Concentration of Clesrovimab on Day 14 (C14days)
Serum concentration of clesrovimab was measured on Day 14.
Time frame: Day 14
Serum Concentration of Clesrovimab on Day 90 (C90days)
Serum concentration of clesrovimab was measured on Day 90.
Time frame: Day 90
Serum Concentration of Clesrovimab on Day 150 (C150days)
Serum concentration of clesrovimab was measured on Day 150.
Time frame: Day 150
Serum Concentration of Clesrovimab on Day 365 (C365days)
Serum concentration of clesrovimab was measured on Day 365.
Time frame: Day 365
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.
Time frame: Days 14, 90, 150, 365 and 545
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Children's Mercy Hospital ( Site 0037)
Kansas City, Missouri, United States
Dartmouth-Hitchcock Medical Center ( Site 0032)
Lebanon, New Hampshire, United States
SUNY Upstate Medical University Hospital ( Site 0029)
Syracuse, New York, United States
WakeMed Health and Hospitals ( Site 0033)
Raleigh, North Carolina, United States
Cincinnati Children's Hospital Medical Center ( Site 0031)
Cincinnati, Ohio, United States
...and 24 more locations