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The purpose of this study is to assess the safety and tolerability of ORN252 in healthy adult participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Ascending Dose | Experimental | Ascending single dose of ORN252 on a specified day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ORN252 | Biological | ORN252 is a lipid nanoparticle encapsulating a circular RNA encoding an anti-CD19 CAR protein. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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] | 29 days |
| Pharmacokinetic (PK) parameters of ORN252 components |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Orna Clinical Trials | Contact | 877-728-6762 | ClinicalTrials@ornatx.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nucleus Network | Recruiting | Herston | Queensland | 4006 | Australia |
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Maximum concentration [Cmax]
| 29 days |
| Pharmacokinetic (PK) parameters of ORN252 components | Time of maximum concentration [Tmax] | 29 days |
| Pharmacokinetic (PK) parameters of ORN252 components | Terminal elimination half-life [t1/2] | 29 days |
| Pharmacokinetic (PK) parameters of ORN252 components | Volume of distribution [Vdss] | 29 days |
| Pharmacokinetic (PK) parameters of ORN252 components | Clearance [CL] | 29 days |
| Pharmacokinetic (PK) parameters of ORN252 components | Area under the concentration versus time curve from time zero to infinity (AUCinf) | 29 days |
| Pharmacodynamic (PD) effects of of ORN252 | Changes in circulating B cell counts and lymphocytes | 12 weeks |
| Immunogenicity of ORN252 | To assess the presence of anti-drug antibodies in healthy adult participants | 12 weeks |