Actively Recruiting
Phase 1 Study to Evaluate Safety and Effects of ORN252 in Healthy Adults Aged 18 to 55
Led by Orna Therapeutics, Inc. · Updated on 2026-04-16
20
Participants Needed
1
Research Sites
12 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of ORN252, a biological investigational treatment, in healthy adult volunteers aged 18 to 55 years. This Phase 1 study aims to understand how the body processes ORN252 and its effects on the immune system, as well as any clinical or laboratory abnormalities that may occur. Participants receive a single ascending dose of ORN252, which is a lipid nanoparticle carrying a circular RNA that encodes an anti-CD19 CAR protein. This dose is administered once on a specified day during the study period. During the 12-week study, participants will undergo safety assessments including clinical exams and laboratory tests to monitor for any adverse effects. Pharmacokinetic and pharmacodynamic evaluations will be performed over 29 days and 12 weeks respectively, alongside immunogenicity testing. Participation involves adhering to study visits and protocol requirements to track how the body responds to ORN252.
CONDITIONS
Brief Title
A Study of ORN252 in Healthy Participants
Research Team
O
Orna Clinical Trials
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