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This study will evaluate the effects of a single dose of AGA2118 in Japanese, Chinese, and Caucasian participants
This Phase 1 ethnobriding study will evaluate the pharmacokinetics, pharmacodynamics, and safety of AGA2118 in Japanese, Chinese, and Caucasian participants. Participants will be administered AGA2118 at the start of the study and followed for 85 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 (Japanese) | Experimental | One of three single ascending dose cohorts of healthy Japanese participants. Participants will receive a single administration of low dose AGA2118. |
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| Cohort 2 (Japanese) | Experimental | One of three single ascending dose cohorts of healthy Japanese participants. Participants will receive a single administration of medium dose AGA2118. |
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| Cohort 3 (Japanese) | Experimental | One of three single ascending dose cohorts of healthy Japanese participants. Participants will receive a single administration of high dose AGA2118. |
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| Cohort 4 (Caucasian) | Experimental | Healthy Caucasian participants will receive a single administration of high dose AGA2118. |
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| Cohort 5 (Chinese) | Experimental | Healthy Chinese participants will receive a single administration of high dose AGA2118. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AGA2118 | Drug | Participants will receive AGA2118 administered by subcutaneous injection |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum concentration (Cmax) | Cmax of AGA2118 after dosing | Day 1 to up to the end of study (85 days post-dose) |
| Time to maximum concentration (Tmax) | Tmax of AGA2118 after dosing | Day 1 to up to the end of study (85 days post-dose) |
| Area under the concentration-time curve (AUC) | AUC of AGA2118 after dosing | Day 1 to up to the end of study (85 days post-dose) |
| Half-life (t1/2) | t1/2 of AGA2118 after dosing | Day 1 to up to the end of study (85 days post-dose) |
| Clearance (CL) | CL of AGA2118 after dosing | Day 1 to up to the end of study (85 days post-dose) |
| Volume of distribution (Vd) | Vd of AGA2118 after dosing | Day 1 to up to the end of study (85 days post-dose) |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-emergent adverse events (TEAEs) | Occurrence of TEAEs | Baseline to the end of study (85 days post-dose) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Angeles EPCU | Glendale | California | 91206 | United States |
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