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The purpose of this study is to examine safety outcomes in healthy volunteers after systemic administration of multiple ascending doses of dalazatide.
The purpose of this study is to examine safety outcomes in healthy volunteers after systemic administration of multiple ascending doses of dalazatide delivered via subcutaneous injection twice per week for a total of 9 doses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dalazatide 5ug | Experimental | 8 subjects, 6 given active agent and 2 given placebo |
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| dalazatide 15ug | Experimental | 8 subjects, 6 given active agent and 2 given placebo |
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| dalazatide 30ug | Experimental | 8 subjects, 6 given active agent and 2 given placebo |
|
| dalazatide 60ug | Experimental | 8 subjects, 6 given active agent and 2 given placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dalazatide | Drug | Different doses of drug, subcutaneous injection twice per week for a total of 9 doses. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subjects with adverse events | From randomization to Day 57 (14 time points) |
| Measure | Description | Time Frame |
|---|---|---|
| Subjects with changes in vital signs | Vital signs include temperature, respiratory rate, supine blood pressure and pulse. | From randomization through Day 57 (14 time points) |
| Subjects with changes in symptom-directed physical examinations |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shawn Iadonato, PhD | Kineta Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PRA International | Lenexa | Kansas | 66219 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 15, 2017 | |
| Reset | Feb 22, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 15, 2017 | Feb 22, 2018 |
| ID | Term |
|---|---|
| C533637 | Shk-186 peptide |
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|
| placebo | Drug | Placebo delivered via subcutaneous administration twice per week for a total of 9 doses |
|
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| From date of randomization to day 57 (14 timepoints) |
| Subjects with changes in 12-lead electrocardiograms | From date of randomization to day 57 (5 timepoints) |
| PK parameters | Parameters include Area under the plasma concentration versus time curve of dalazatide (AUC) | pre-dose, 15 minutes post dose, 30 minutes post dose, 1 hour post dose, 2 hours post dose, 4 hours post dose, 8 hours post dose, 12 hours post dose |
| Presence of specific anti-drug antibody | Serum evaluated for specific anti-drug antibody using ELISA-based immunoassay. | From date of randomization through Day 57 (4 timepoints). |