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This is a randomized, double-blind, placebo-controlled, single ascending dose trial evaluating the safety, tolerability, PK, and immunogenicity of STAR-0310 in healthy adult participants. There are 4 planned cohorts and potentially up to 1 additional cohort which may comprise of healthy adult participants of Japanese descent.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| STAR-0310 Dose 1 | Experimental | Participants will be randomized to receive STAR-0310 or matching placebo |
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| STAR-0310 Dose 2 | Experimental | Participants will be randomized to receive STAR-0310 or matching placebo |
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| STAR-0310 Dose 3 | Experimental | Participants will be randomized to receive STAR-0310 or matching placebo |
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| STAR-0310 Dose 4 | Experimental | Participants will be randomized to receive STAR-0310 or matching placebo |
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| STAR-0310 in Participants of Japanese Descent | Experimental | Participants will be randomized to receive STAR-0310 or matching placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STAR-0310 | Drug | STAR-0310 will be administered as a subcutaneous bolus injection. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing Treatment-emergent Adverse Events | [Time Frame: Day 1 through Day 252] |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Concentration of STAR-0310 | Blood samples will be collected to measure the serum concentration of STAR-0310 before and after study drug administration. | [Time Frame: Day 1 (predose up to 2 hours before study drug administration, and 12 hours post dose), Days 2, 3, 7, 10, 14, 21, 28, 42, 56, 84, 112, 140, 168, 196, 224, 252 ] |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Austin Clinical Research Unit - Early Clinical Development | Austin | Texas | 78744 | United States |
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| Placebo | Drug | Placebo will be administered as a subcutaneous bolus injection. |
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| Number of Participants with Anti-drug Antibodies to STAR-0310 |
Blood samples will be collected to assess the formation of STAR-0310 anti-drug antibodies in serum before and after study drug administration. |
| [Time Frame: Day 1 predose, Days 14, 28, 84, 168, 252 ] |