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This first-in-human (FIH) study aims to characterize the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of JANX011 dosed subcutaneously (and potentially intravenously) in healthy adult volunteers (HVs) to gain insight into its therapeutic utility in patients with autoimmune diseases.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation | Experimental | Dosage per cohort will increase to determine the maximum tolerable dose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JANX011 | Drug | JANX011 is administered subcutaneously, one time. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence, severity, and relatedness of TEAEs, treatment-emergent SAEs, and treatment-emergent AESIs. | Up to 85 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Janux Therapeutics | Contact | 858-206-8471 | ARMV-011-001_ct.gov@januxrx.com |
| Name | Affiliation | Role |
|---|---|---|
| Janux Therapeutics, MD | Janux Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CMAX | Recruiting | Adelaide | South Australia | 5000 | Australia |
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Subjects will receive one dose of JANX011 subcutaneously. Dosage per cohort will increase to determine the maximum tolerable dose.
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