ORN252 in healthy adults
Official title: A Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ORN252 in Healthy Participants
Run by Orna Therapeutics, Inc. · NCT07439796 · Data updated 2026-11-12
This will test whether ORN252 is safe and well tolerated in healthy adult men and women.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Orna Therapeutics, Inc. Industry-sponsored |
| Locations | 1 site (Herston, Queensland) |
| Status | Recruiting |
| Started | March 16, 2026 |
| Main results expected | December 2026 |
| Study ends | March 2027 |
| Registry record updated | April 16, 2026 |
| Trial ID | NCT07439796 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Healthy adult men and women who pass screening, have no clinically significant organ dysfunction, and can comply with study visits and procedures are ideal candidates.
✕Probably not a fit
People with active medical conditions, significant organ dysfunction, recent investigational drug exposure, or those seeking direct therapeutic benefit are unlikely to receive clinical benefit from this safety-focused study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 1 interventional study enrolls healthy adult volunteers who will receive ORN252 and be monitored for safety and tolerability. Participants will undergo screening with medical history, physical exam, and laboratory tests, receive dosing per protocol at a single site, and return for scheduled follow-up visits where vital signs, labs, and adverse events are recorded. People with significant organ dysfunction or recent use of another investigational product are excluded. The study is sponsored by Orna Therapeutics and conducted at the Nucleus Network clinic in Herston, Queensland.
Why it matters
Potential benefit: If ORN252 is shown to be safe and tolerable, it could move forward to later studies that test whether it can treat specific diseases.
How similar studies have gone: Phase 1 safety studies of novel therapeutics are a common first step and have enabled many drugs to advance, but there are no published efficacy data for ORN252 specifically.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Nucleus Network
Herston, Queensland, Australia Recruiting
Study contacts
- Study coordinator: Orna Clinical Trials
- Email: ClinicalTrials@ornatx.com
- Phone: 877-728-6762
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.