A Study of Annual Doses of MK-1406/CD388 in Healthy Adults (MK-1406-006/CD388.SQ.2.07)
- 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.
- Acronym
- NAVIGATE-2
- Short title
- A Study of Annual Doses of MK-1406/CD388 in Healthy Adults (MK-1406-006/CD388.SQ.2.07)
- Official title
- A Phase 2, Open-Label, Long-Term Study to Evaluate the Safety, Pharmacokinetics, and Occurrence of Anti-Drug Antibodies in Healthy Participants Following Annual Doses of CD388, a Novel Long-Acting Antiviral Conjugate
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Active, not recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Completion date
- 2027-07-31
- First posted
- 2025-11-10
- Registry last updated
- 2026-08-20
- Primary completion date
- 2027-07-31
- Start date
- 2025-10-29
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07225959
- ClinicalTrials.gov ID
- NCT07225959
- Registry record
- Open registry record
- Allocation
- Not applicable
- Model
- Single group
- Purpose
- Prevention
- Masking
- No masking
Number of Participants with Treatment-Induced Anti-Drug Antibodies (ADAs)
Timeframe: 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
Timeframe: 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.
Number of participants with ≥1 Adverse Event (AE)
Timeframe: 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
Timeframe: 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
Timeframe: 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)
Timeframe: 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
Timeframe: 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.
Timeframe: 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.
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Maximum age
- 66 Years
- Healthy volunteers
- Yes
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.
The main exclusion criteria include but are not limited to the following:
- Have a contraindication to subcutaneous (SQ) injections and venipunctures (eg, bleeding disorders).
- Has a known or suspected allergy or history of anaphylaxis or other serious adverse events (SAEs) to zanamivir (following administration of inhaled or intravenous formulations), monoclonal antibodies, or any of the components of CD388/MK-1406.
- Floridian Clinical Research ( Site 0102)Miami Lakes, United States
- Floridian Clinical ResearchMiami Lakes, United States
- Spartanburg Medical Research ( Site 0101)Spartanburg, United States
- Spartanburg Medical ResearchSpartanburg, United States
- hVIVO Serviced LimitedLondon, United Kingdom
- hVIVO ( Site 0001)London, United Kingdom
- Related resource (www.merckclinicaltrials.com)
- MK-1406-006
- CD388.SQ.2.07