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A Phase 1 Randomized, Double-Blind Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Bioavailability of NSI-8226 in Healthy Participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A | Experimental | NSI-8226 |
|
| Cohort B | Experimental | NSI-8226 |
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| Cohort C | Experimental | NSI-8226 |
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| Cohort D | Experimental | NSI-8226 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cohort A | Biological | Administered IV High dose |
| |
| Cohort B |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability | To evaluate the incidence of treatment emergent adverse events of NSI-8826 in healthy participants according to Common Terminology Criteria for Adverse Events (CTCAE) V4.0 | 140 days |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute bioavailability | Pharmacokinetics (PK) and absolute bioavailability of NSI-8226 in healthy participants. | 140 days |
| Concentration of immunogenicity | Immunogenicity profile of NSI-8226 in healthy participants. |
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Key Inclusion Criteria:
1. At the time of initial screening, in general good health (age 18 to 65 years);
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew W Lee, MD | Vice President, Clinical Research | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Cincinnati | Ohio | 45227 | United States |
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| Biological |
Administered SC Low Dose |
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| Cohort C | Biological | Administered SC Mid Dose |
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| Cohort D | Biological | Administered SC High Dose |
|
| 140 days |
| Parameters in healthy participants | Pharmacodynamic (PD) parameters of NSI-8226 in healthy participants. | 140 days |