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This is a Phase 1 study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of JADE101 in healthy Japanese and Chinese participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JADE101 Groups 1 and 2 | Experimental | Subcutaneous (SC) injection of JADE101 |
|
| JADE101 Groups 3 and 4 | Experimental | Subcutaneous (SC) injection of JADE101 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JADE101 | Drug | JADE101 is supplied as sterile solution to be administered by SC injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of single dose of JADE101 in healthy Japanese and Chinese participants | Incidence of treatment-emergent adverse events | Day 1 through 48 weeks |
| Cmax | Maximum observed serum concentration | Day 1 through 48 weeks |
| Tmax | Time to reach Cmax | Day 1 through 48 weeks |
| AUClast | The area under the concentration-time curve from time zero to the time of the last observed quantifiable (non-zero) concentration | Day 1 through 48 weeks |
| T1/2 | Apparent first-order terminal elimination half-life | Day 1 through 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity of JADE101 in healthy Japanese and Chinese participants | Incidence and titers of serum anti-drug antibodies (ADAs) | Day 1 through 48 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Han | Contact | +1-888-228-7425 | study.losangeles@parexel.com |
| Name | Affiliation | Role |
|---|---|---|
| Li Li, MD | Jade Biosciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parexel Early Phase Clinical Unit (EPCU) | Recruiting | Glendale | California | 91206 | United States |
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