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Recruiting NCT07439796

A Study of ORN252 in Healthy Participants

Phase I Interventional Healthy Volunteers - Male and Female

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ORN252.
Who it may be relevant to
Registry conditions: Healthy Volunteers - Male and Female. Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Australia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

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

Primary outcome measures

  • The incidence and severity of safety, clinical, and laboratory abnormalities in healthy adult participants. [Time frame: 12 weeks]
Secondary outcome measures (9)
  • 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Sequential
Masking
Open label
Primary purpose
Basic science

Study locations

Australia · 1 center
  • Nucleus Network — Herston

Identifiers

NCT: NCT07439796 · AD25201

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗