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| Name | Class |
|---|---|
| Altasciences Company Inc. | INDUSTRY |
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This is a Phase 1, randomized, double-blind, placebo-controlled, single dose, first in human safety, tolerability, and pharmacokinetic study of SPY003-207 in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAD Cohorts 1-6 Experimental Arm | Experimental | Participants will receive a single dose of SPY003-207 in a dose escalation format |
|
| SAD Cohorts 1-6 Placebo Arm | Placebo Comparator | Participants will receive a single dose of placebo |
|
| SAD Cohort 7, Experimental Arm | Experimental | Participants of Chinese descent will receive a single dose of SPY003-207-101 |
|
| SAD Cohort 7, Placebo Arm | Placebo Comparator | Participants of Chinese descent will receive a single dose of placebo |
|
| MAD Cohorts 1 Experimental Arm | Experimental | Participants will receive two doses of SPY003-207-101 in a dose escalation format |
|
| MAD Cohorts 1 Placebo Arm | Placebo Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPY003-207 | Drug | Experimental |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment emergent adverse events | Incidence, severity, and causal relationship of TEAEs | Up to 63 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum concentration after a single dose | Up to 63 weeks |
| Tmax | Time to reach maximum concentration after a single dose | Up to 63 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Deanna Nguyen, MD | Spyre Therapeutics | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spyre Site 2 | Cypress | California | 90630 | United States | ||
| Spyre Site 1 |
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Participants will receive two doses of placebo
|
| Placebo | Other | Placebo |
|
| t1/2 | Half life after a single dose | Up to 63 weeks |
| AUC | Area under the curve after a single dose | Up to 63 weeks |
| ADA | Incidence of anti-drug antibody after a single dose | Up to 63 weeks |
| Montreal |
| Quebec |
| H3P 3P1 |
| Canada |