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This study will test the safety and effects of SBT115301 when given as a single dose to healthy adult volunteers. It is the first study being done in humans. Increasing dose levels will be given after the safety at lower dose levels is shown. Some participants will receive placebo, and neither the participants or the study staff will know what drug (SBT115301 or placebo) is being given.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Intramuscular (IM) dose level 1 |
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| Cohort 2 | Experimental | IM dose level 2 |
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| Cohort 3 | Experimental | IM dose level 3 |
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| Cohort 4 | Experimental | IM dose level 4 |
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| Cohort 5 | Experimental | Intravenous (IV) dose level 1 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SBT115301 | Biological | Immunomodulatory dimeric fusion protein |
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| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Number of participants with treatment-emergent adverse events | Day of treatment to end of follow-up period (71 days for Cohorts 1-4; 140 days for Cohort 5) |
| Serious adverse events | Number of participants with serious adverse events | Baseline to end of follow-up period (71 days for Cohorts 1-4; 140 days for Cohort 5) |
| Measure | Description | Time Frame |
|---|---|---|
| SBT115301 Serum Concentration | Serum concentration of SBT115301 | Day 1 to Day 72 (Cohorts 1-4) or Day 141 (Cohort 5) |
| Pharmacokinetic Parameters: Cmax | Maximum serum concentration (Cmax) of SBT115301 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michelle Valentine, DO | Celerion | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion | Tempe | Arizona | 85283 | United States |
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Placebo-controlled, sequential escalating dose cohorts
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| Placebo | Biological | Matched placebo |
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| Day 1 to Day 72 (Cohorts 1-4) or Day 141 (Cohort 5) |
| Pharmacokinetic Parameters: Tmax | Time of maximum SBT115301 serum concentration (Tmax) | Day 1 to Day 72 (Cohorts 1-4) or Day 141 (Cohort 5) |
| Pharmacokinetic Parameters: AUC(0-last) | Area under the serum concentration-time curve (AUC) from time 0 to the last measurable serum concentration | Day 1 to Day 72 (Cohorts 1-4) or Day 141 (Cohort 5) |
| Pharmacokinetic Parameters: AUC(0-inf) | Area under the serum concentration-time curve from time 0 extrapolated to infinity | Day 1 to Day 72 (Cohorts 1-4) or Day 141 (Cohort 5) |
| Pharmacokinetic Parameters: t1/2 | Terminal elimination half-life (t1/2) | Day 1 to Day 72 (Cohorts 1-4) or Day 141 (Cohort 5) |
| Anti-Drug Antibodies | Number of participants with anti-drug antibodies | Day 1 to Day 72 (Cohorts 1-4) or Day 141 (Cohort 5) |