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The purpose of this dose-escalation study is to assess the safety and pharmacodynamics of single and multiple doses of QBKPN SSI, administered subcutaneously to healthy adult volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAD Cohort 1 | Experimental | Single dose of 0.05 mL QBKPN or Placebo |
|
| SAD Cohort 2 | Experimental | Single dose of 0.10 mL QBKPN or Placebo |
|
| SAD Cohort 3 | Experimental | Single dose of 0.20 mL QBKPN or Placebo |
|
| SAD Cohort 4 | Experimental | Single dose of 0.40 mL QBKPN or Placebo |
|
| SAD Cohort 5 | Experimental | Single dose of 0.80 mL QBKPN or Placebo |
|
| SAD Cohort 6 | Experimental | Single dose of 1.2 mL QBKPN or Placebo |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QBKPN | Biological | QBKPN Site Specific Immunomodulators |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse events [Safety and Tolerability] | Incidence, severity, and dose-relationship of adverse events, vital signs, and clinical laboratory parameters | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in cellular biomarkers over time | Absolute (#/mL) and Differentials (%) | 2 weeks |
| Immunological biomarkers analysis | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| MAD Cohorts only: Changes in cell surface markers on neutrophils and monocytes over time | 2 weeks | |
| MAD cohorts only: Gene Expression Analysis | 2 weeks | |
| Phenotype and Genotype Correlation [Exploratory gene association analysis] |
Inclusion Criteria:
Exclusion Criteria:
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|
| MAD Cohort 1 | Experimental | 5 doses of QBKPN or Placebo administered every other day (using one of the dose from the SAD Cohort) |
|
| MAD Cohort 2 | Experimental | 5 doses of QBKPN or Placebo administered every other day (using one of the dose from the SAD Cohort) |
|
| MAD Cohort 3 | Experimental | 5 doses of QBKPN or Placebo administered every day (using one of the dose from the SAD Cohort) |
|
| MAD Cohort 4 | Experimental | 5 doses of QBKPN or Placebo administered every day (using one of the dose from the SAD Cohort) |
|
| Placebo | Other | Placebo |
|
| 2 weeks |