A Study of Annual Doses of MK-1406/CD388 in Healthy Adults (MK-1406-006/CD388.SQ.2.07) (NCT07225959)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Floridian Clinical Research ( Site 0102) — Miami Lakes, Florida
Age range: 18 Years to 66 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (6 Sites)
- 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
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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- A Study to Determine the Safety and Tolerability of AG-236 and How it is Absorbed, Broken Down, and Eliminated From the Body in Healthy Participants — Madison, Wisconsin
- Comparing the Extent to Which Two Evolocumab Drug Products Are Made Available in the Body After a Single Subcutaneous Dose. — Anaheim, California
- A Trial to Evaluate the Effect of CD388/MK1406 on the Immunogenicity of Fluzone® HD Vaccine (CD388.SQ.1.08/MK-1406-007) — Glendale, California
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.