Healthy Volunteers - Male and FemalePhase 1NCT07439796
A Study of ORN252 in Healthy Participants
A Phase 1 study testing ORN252 in people with Healthy Volunteers - Male and Female, run by Orna Therapeutics, Inc. at 1 site in Australia.
Trial summary
The purpose of this study is to assess the safety and tolerability of ORN252 in healthy adult participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers - Male and Female
- What is being tested?
- ORN252
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteAustralia
- Study dates
- 16 Mar 2026to Mar 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Nucleus Network
Herston, Queensland, 4006
Principal Investigator, +61 (07) 3707 2720, brisbane@nucleusnetwork.com
About this study
Official title: A Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ORN252 in Healthy Participants
The purpose of this study is to assess the safety and tolerability of ORN252 in healthy adult participants.
- Conditions
- Healthy Volunteers - Male and Female
- Being tested
- ORN252
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ORN252Biological
ORN252 is a lipid nanoparticle encapsulating a circular RNA encoding an anti-CD19 CAR protein.
| Study group | Role | What they receive |
|---|---|---|
| Single Ascending Dose | Experimental | Ascending single dose of ORN252 on a specified day Receives: Biological: ORN252 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence and severity of safety, clinical, and laboratory abnormalities in healthy adult participants.
To evaluate the safety and tolerability of ORN252 administered to healthy adult participants.
Measured: 12 weeks
Secondary outcomes (9)
Pharmacokinetic (PK) parameters of ORN252 components
Area under the concentration versus time curve from time zero to the time of the last quantifiable concentration [AUClast]
Measured: 29 days
Pharmacokinetic (PK) parameters of ORN252 components
Maximum concentration [Cmax]
Measured: 29 days
Pharmacokinetic (PK) parameters of ORN252 components
Time of maximum concentration [Tmax]
Measured: 29 days
Pharmacokinetic (PK) parameters of ORN252 components
Terminal elimination half-life [t1/2]
Measured: 29 days
Pharmacokinetic (PK) parameters of ORN252 components
Volume of distribution [Vdss]
Measured: 29 days
Pharmacokinetic (PK) parameters of ORN252 components
Clearance [CL]
Measured: 29 days
Pharmacokinetic (PK) parameters of ORN252 components
Area under the concentration versus time curve from time zero to infinity (AUCinf)
Measured: 29 days
Pharmacodynamic (PD) effects of of ORN252
Changes in circulating B cell counts and lymphocytes
Measured: 12 weeks
Immunogenicity of ORN252
To assess the presence of anti-drug antibodies in healthy adult participants
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start16 Mar 2026
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Volunteers - Male and FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Orna Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07439796
- Sponsor's protocol ID
- AD25201
- Status last verified
- Apr 2026
- First submitted
- 10 Feb 2026
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ORN252 in Healthy Participants
- ClinicalTrials.gov ID
- NCT07439796
- Acronym / sponsor ID
- AD25201
- Conditions
- Healthy Volunteers - Male and Female
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Orna Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Mar 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the safety and tolerability of ORN252 in healthy adult participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Ascending Dose | Experimental | Biological: ORN252Ascending single dose of ORN252 on a specified day |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ORN252ORN252 is a lipid nanoparticle encapsulating a circular RNA encoding an anti-CD19 CAR protein. | Biological | Single Ascending Dose |
Primary outcome
The incidence and severity of safety, clinical, and laboratory abnormalities in healthy adult participants.
Time frame: 12 weeks
To evaluate the safety and tolerability of ORN252 administered to healthy adult participants.
9 secondary outcomes
Pharmacokinetic (PK) parameters of ORN252 components
Time frame: 29 days
Pharmacokinetic (PK) parameters of ORN252 components
Time frame: 29 days
Pharmacokinetic (PK) parameters of ORN252 components
Time frame: 29 days
Pharmacokinetic (PK) parameters of ORN252 components
Time frame: 29 days
Pharmacokinetic (PK) parameters of ORN252 components
Time frame: 29 days
Pharmacokinetic (PK) parameters of ORN252 components
Time frame: 29 days
Pharmacokinetic (PK) parameters of ORN252 components
Time frame: 29 days
Pharmacodynamic (PD) effects of of ORN252
Time frame: 12 weeks
Immunogenicity of ORN252
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ORN252 in people with Healthy Volunteers - Male and Female, run by Orna Therapeutics, Inc. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Orna Clinical Trials (877-728-6762, ClinicalTrials@ornatx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence and severity of safety, clinical, and laboratory abnormalities in healthy adult participants. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.