Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Phase
Phase 2
Started
2025-10-29
Last updated
2026-08-20
Condition(s) studied
Healthy Participants
Investigational drug(s) / intervention(s)
MK-1406 Injection
MK-1406 Injection: MK-1406 liquid for injection administered subcutaneously
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
66 Years
Healthy volunteers
Accepted
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 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.
Primary outcome measure(s)
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.
Trial sites (6)
Facility
City
Region
Status
Floridian Clinical Research ( Site 0102)
Miami Lakes
Florida
Floridian Clinical Research
Miami Lakes
Florida
Spartanburg Medical Research ( Site 0101)
Spartanburg
South Carolina
Spartanburg Medical Research
Spartanburg
South Carolina
hVIVO Serviced Limited
London
England
hVIVO ( Site 0001)
London
London, City of
More Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) trials in the UK
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.