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Recruiting

NCT Number: NCT07439796

A Study of ORN252 in Healthy Participants

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

Recruiting

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Key information

Conditions

Healthy Volunteers - Male and Female

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ORN252

Biological

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Pharmacokinetic (PK) parameters of ORN252 components

    Time frame: 29 days

    Area under the concentration versus time curve from time zero to the time of the last quantifiable concentration [AUClast]

  2. Pharmacokinetic (PK) parameters of ORN252 components

    Time frame: 29 days

    Maximum concentration [Cmax]

  3. Pharmacokinetic (PK) parameters of ORN252 components

    Time frame: 29 days

    Time of maximum concentration [Tmax]

  4. Pharmacokinetic (PK) parameters of ORN252 components

    Time frame: 29 days

    Terminal elimination half-life [t1/2]

  5. Pharmacokinetic (PK) parameters of ORN252 components

    Time frame: 29 days

    Volume of distribution [Vdss]

  6. Pharmacokinetic (PK) parameters of ORN252 components

    Time frame: 29 days

    Clearance [CL]

  7. Pharmacokinetic (PK) parameters of ORN252 components

    Time frame: 29 days

    Area under the concentration versus time curve from time zero to infinity (AUCinf)

  8. Pharmacodynamic (PD) effects of of ORN252

    Time frame: 12 weeks

    Changes in circulating B cell counts and lymphocytes

  9. Immunogenicity of ORN252

    Time frame: 12 weeks

    To assess the presence of anti-drug antibodies in healthy adult participants

Study contacts

Contact information is provided by the study sponsor or research team.

Orna Clinical Trials

CONTACT

[email protected]

877-728-6762

Sponsors and collaborators

Lead sponsor

Orna Therapeutics, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Feb 27, 2026
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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