ORN252 in healthy adults

A Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ORN252 in Healthy Participants

This will test whether ORN252 is safe and well tolerated in healthy adult men and women.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Orna Therapeutics, Inc. (Industry-sponsored)
• Locations: 1 site (Herston, Queensland)
• Trial ID: NCT07439796 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Herston, Queensland

• Nucleus Network — Herston, Queensland, Australia (Recruiting)

Study contacts

• Study coordinator: Orna Clinical Trials

Conditions Healthy Volunteers - Male and Female