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This is a Phase 1, first-in-human study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of JADE101 compared to placebo in healthy participants.
This is a single center, Phase 1, double-blind, placebo-controlled, randomized, first-in-human (FIH), single ascending dose study evaluating the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of JADE101 in healthy participants. The study will enroll approximately 32 healthy volunteers. JADE101 will be administered by a subcutaneous injection. The results of this study will help inform the dosing and frequency of dosing in future studies of JADE101.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JADE101 | Experimental | Subcutaneous (SC) injection of JADE101 |
|
| Placebo | Placebo Comparator | Subcutaneous (SC) injection of placebo |
|
| 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 Ascending Doses of JADE101 in Healthy Participants | Incidence of treatment-emergent adverse events | Day 1 through 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum observed serum concentration | Day 1 through 48 weeks |
| Tmax | Time to reach Cmax | Day 1 through 48 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Li Li, MD | Jade Biosciences, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NZCR | Auckland | New Zealand |
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| Placebo |
| Drug |
Placebo solution to be administered at a matching volume by SC injection. |
|
| 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 |