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This is a Phase 1 randomized, double blinded, placebo-controlled, single dose escalation study to evaluate the safety, tolerability, and PK of 611 in healthy volunteers.
Total duration of the study period per subject is about 4 months broken down as follows:
The screening period is up to 28 days, one dose treatment, and follow- up period is up to 71±7 days (90±9 days for Cohorts 1 and 2).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | 611 dose 1 (45mg) plus placebo |
|
| Cohort 2 | Experimental | 611 dose 2 (150mg) plus placebo |
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| Cohort 3 | Experimental | 611 dose 3 (300mg) plus placebo |
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| Cohort 4 | Experimental | 611 dose 4 (450mg) plus placebo |
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| Cohort 5 | Experimental | 611 dose 5 (600mg) plus placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | placebo as a single SC injection on Day 1; |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With TEAEs | Incidence of treatment-emergent adverse events (TEAEs) will be summarized by SOC and PT for each treatment group, and also be summarized by severity and association with the study treatments. | up to 71days (90 days for Cohorts 1 and 2) |
| Measure | Description | Time Frame |
|---|---|---|
| PK | PK parameters not limit to Cmax | up to 71days (90 days for Cohorts 1 and 2) |
| Incidence of immunogenicity | ADA, and NAbs if ADA is positive |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Dallas Clinical Research Unit | Dallas | Texas | 75247 | United States |
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| ID | Term |
|---|---|
| C071192 | entacapone |
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| 611 | Drug | 611 as a single SC injection on Day 1; |
|
| up to 71days (90 days for Cohorts 1 and 2) |