Healthy Participants
Conditions
Keywords
Influenza, Antiviral Agents
Brief summary
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.
Detailed description
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.
Interventions
COMBINATION_PRODUCTMK-1406 Injection
MK-1406 liquid for injection administered subcutaneously
Sponsors
Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 66 Years
Healthy volunteers
Yes
Inclusion criteria
The main inclusion criteria include but are not limited to the following: * Be in stable health * Has previously completed participation in study CD388.SQ.2.05/MK-1406-004, and received a subcutaneous (SC) CD388/MK-1406 dose of either 150 mg, 300 mg or 450 mg.
Exclusion criteria
The main
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Treatment-Induced Anti-Drug Antibodies (ADAs) | Periods 1 and 2: Day 1, Day 29, Day 85, Day 169, and Day 197 | Participants are evaluated for the occurrence of treatment-induced ADAs following administration of each annual dose of MK-1406. |
| Number of Participants with Treatment-Boosted ADAs | Periods 1 and 2: Day 1, Day 29, Day 85, Day 169, and Day 197 | Participants are evaluated for the occurrence of treatment-boosted ADAs following administration of each annual dose of MK-1406. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with ≥1 Adverse Event (AE) | Period 1: Up to approximately Day 280. Period 2: Up to approximately Day 197. | 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. |
| Number of Participants Who Discontinued from the Study Due to an AE | Period 1: Up to approximately Day 280. Period 2: Up to approximately Day 197. | 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. |
| Number of Participants with a Solicited Injection-site AE | Up to approximately Day 8 post dose | 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. |
| Number of Participants with a Serious Adverse Event (SAE) | Period 1: Up to approximately Day 280. Period 2: Up to approximately Day 197. | 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. |
| Plasma Concentration Following Administration of MK-1406 | Periods 1 and 2: Pre-dose, Day 8, Day 29, Day 85, Day 169, Day 197 | Blood samples will be collected at multiple time points to assess the plasma concentrations of MK-1406. |
| Plasma concentration of MK-1406 by anti-drug antibody (ADA) status. | Periods 1 and 2: Day 197 | Blood samples will be collected to assess the plasma concentration of MK-1406 where ADAs are present in participants administered MK-1406. |
Countries
United Kingdom, United States
Contacts
STUDY_DIRECTORMedical Director
Merck Sharp & Dohme LLC
Outcome results
None listed