The goal of this clinical study is to learn if giving repeated annual doses of MK-1406 (CD388) is safe and how the body reacts to it in healthy adults who have already received one dose without serious side effects. The study aims to determine if the body makes antibodies against MK-1406 after repeated doses, which might affect how the drug works or how safe it is, and to better understand the safety and tolerability of repeated doses. Participants will receive two doses of MK-1406 over two years and be monitored for 18 months. Researchers will check for immune responses against the drug, watch for any side effects, and measure how the drug behaves in the body over time. This study is based on the idea that people who tolerated MK-1406 well before will likely continue to tolerate it safely with repeated annual dosing, and that the risk of immune reactions will remain low.
This is a Phase 2, open-label, long-term study to evaluate the occurrence anti-drug antibodies (ADAs) directed to MK-1406 (CD388) following administration of 2 annual doses of MK-1406 in healthy participants during an 18-month period. All participants previously completed study CD388.SQ.2.05/MK-1406-004, having received a dose of the active drug without experiencing any serious adverse events (SAEs) during that study. This study will also evaluate the safety and tolerability of MK-1406 and the pharmacokinetics (PK) of MK-1406 following repeated annual dosing.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
400
MK-1406 liquid for injection administered subcutaneously
Floridian Clinical Research ( Site 0102)
Miami Lakes, Florida, United States
Floridian Clinical Research
Miami Lakes, Florida, United States
Spartanburg Medical Research ( Site 0101)
Spartanburg, South Carolina, United States
Spartanburg Medical Research
Spartanburg, South Carolina, United States
hVIVO Serviced Limited
London, England, United Kingdom
hVIVO ( Site 0001)
London, London, City of, United Kingdom
Number of Participants with Treatment-Induced Anti-Drug Antibodies (ADAs)
Participants are evaluated for the occurrence of treatment-induced ADAs following administration of each annual dose of MK-1406.
Time frame: Periods 1 and 2: Day 1, Day 29, Day 85, Day 169, and Day 197
Number of Participants with Treatment-Boosted ADAs
Participants are evaluated for the occurrence of treatment-boosted ADAs following administration of each annual dose of MK-1406.
Time frame: Periods 1 and 2: Day 1, Day 29, Day 85, Day 169, and Day 197
Number of participants with ≥1 Adverse Event (AE)
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants with ≥1 AE will be assessed.
Time frame: Period 1: Up to approximately Day 280. Period 2: Up to approximately Day 197.
Number of Participants Who Discontinued from the Study Due to an AE
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinued the study because of an AE will be assessed.
Time frame: Period 1: Up to approximately Day 280. Period 2: Up to approximately Day 197.
Number of Participants with a Solicited Injection-site AE
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The solicited injection-site AEs assessed are redness/erythema, swelling, and tenderness/pain. The number of participants with a solicited injection-site AE will be assessed.
Time frame: Up to approximately Day 8 post dose
Number of Participants with a Serious Adverse Event (SAE)
An SAE is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, is a cancer, is an overdose, or is another important medical event. The number of participants with an SAE will be assessed.
Time frame: Period 1: Up to approximately Day 280. Period 2: Up to approximately Day 197.
Plasma Concentration Following Administration of MK-1406
Blood samples will be collected at multiple time points to assess the plasma concentrations of MK-1406.
Time frame: Periods 1 and 2: Pre-dose, Day 8, Day 29, Day 85, Day 169, Day 197
Plasma concentration of MK-1406 by anti-drug antibody (ADA) status.
Blood samples will be collected to assess the plasma concentration of MK-1406 where ADAs are present in participants administered MK-1406.
Time frame: Periods 1 and 2: Day 197
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.