A Study of ORN252 in Healthy Participants

Phase 1RecruitingNCT07439796

Orna Therapeutics, Inc.20 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy Volunteers - Male and Female

Interventions

ORN252BIOLOGICAL

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Nucleus Network

Herston, Queensland, Australia

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 12 weeks