NCT07439796

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
9mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress26%
Mar 2026Mar 2027

First Submitted

Initial submission to the registry

February 10, 2026

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 27, 2026

Completed
17 days until next milestone

Study Start

First participant enrolled

March 16, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

April 16, 2026

Status Verified

April 1, 2026

Enrollment Period

9 months

First QC Date

February 10, 2026

Last Update Submit

April 13, 2026

Conditions

Healthy Volunteers - Male and Female

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 weeks

Secondary Outcomes (9)

  • Pharmacokinetic (PK) parameters of ORN252 components

    29 days

  • Pharmacokinetic (PK) parameters of ORN252 components

    29 days

  • Pharmacokinetic (PK) parameters of ORN252 components

    29 days

  • Pharmacokinetic (PK) parameters of ORN252 components

    29 days

  • Pharmacokinetic (PK) parameters of ORN252 components

    29 days

  • +4 more secondary outcomes

Study Arms (1)

Single Ascending Dose

EXPERIMENTAL

Ascending single dose of ORN252 on a specified day

Biological: ORN252

Interventions

ORN252BIOLOGICAL

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

Single Ascending Dose

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Clinically significant history or presence of organ dysfunction
  • Use of any investigational product within 3 months, or 5 half-lives, whichever longer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nucleus Network

Herston, Queensland, 4006, Australia

RECRUITING

Central Study Contacts

Orna Clinical Trials

CONTACT

877-728-6762ClinicalTrials@ornatx.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2026

First Posted

February 27, 2026

Study Start

March 16, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

March 1, 2027

Last Updated

April 16, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)