Actively Recruiting
A Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ORN252 in Healthy Participants
Led by Orna Therapeutics, Inc. · Updated on 2026-04-16
20
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female participants who are healthy as determined by the Investigator based on review of medical history, physical examination, and laboratory tests
- Participant is willing and able to comply with study visits and other protocol requirements
- Other protocol specific inclusion criteria may apply
You will not qualify if you...
- Clinically significant history or presence of organ dysfunction
- Use of any investigational product within 3 months, or 5 half-lives, whichever longer
- Other protocol specific exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 weeks
Participants receive a single ascending dose of ORN252 and are monitored for safety, pharmacokinetics, and pharmacodynamics.
Multiple visits over 12 weeks to assess safety and pharmacokinetics
Trial Site Locations
Total: 1 location
1
Nucleus Network
Herston, Queensland, Australia, 4006
Actively Recruiting
Research Team
O
Orna Clinical Trials
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here