Study to Evaluate CAY001 in Healthy Volunteers (NCT06845839)
A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenously Administered CAY001 in Healthy Volunteer Subjects
🩺 Plain-English Summary (8th-Grade Level)
This is a Phase 1, first-in-human, randomized, double-blind, placebo-controlled, single ascending dose, sequential group study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of CAY001 when administered to healthy male and female subjects. Three dose levels will be evaluated with a total of approximately 24 subjects.
Who can join: Review the eligibility criteria below.
Location: TKL Research — Fair Lawn, New Jersey
Age range: 18 Years to 50 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 (1 Sites)
- TKL Research — Fair Lawn, New Jersey
📞 Contact the Study Coordinator
Phone: (201) 587-0500
Email: irios@tklresearch.onmicrosoft.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 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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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.