Clinical trial Recruiting at 1 site Phase 1 Interventional Ages 18 to 55

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.

More Healthy Adult Male and Female Volunteers trials

Quick facts

PhasePhase 1
Study typeInterventional
Ages18 Years to 55 Years
SexAll
Enrollment20 (estimated)
SponsorOrna Therapeutics, Inc.
Industry-sponsored
Locations1 site (Herston, Queensland)
StatusRecruiting
StartedMarch 16, 2026
Main results expectedDecember 2026
Study endsMarch 2027
Registry record updatedApril 16, 2026
Trial IDNCT07439796 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.