Ireland
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Recruiting Phase 1

A Study of ORN252 in Healthy Participants

NCT07439796 · tracked via the Priya Life Science Australia tracker
Sponsor
Orna Therapeutics, Inc
Phase
Phase 1
Started
2026-03-16
Last updated
2026-04-16

Condition(s) studied

Healthy Volunteers - Male and Female

Investigational drug(s) / intervention(s)

ORN252

ORN252: ORN252 is a lipid nanoparticle encapsulating a circular RNA encoding an anti-CD19 CAR protein.

Study summary

The purpose of this study is to assess the safety and tolerability of ORN252 in healthy adult participants.

Eligibility

Sex
ALL
Min age
18 Years
Max age
55 Years
Healthy volunteers
Accepted
Inclusion Criteria: * 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 Exclusion Criteria: * 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

Primary outcome measure(s)

  • The incidence and severity of safety, clinical, and laboratory abnormalities in healthy adult participants. — 12 weeks
    To evaluate the safety and tolerability of ORN252 administered to healthy adult participants.

Trial sites (1)

FacilityCityRegionStatus
Nucleus Network Herston Queensland Recruiting
Official registry record

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.

View NCT07439796 on ClinicalTrials.gov ↗ ← All trials in Australia