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This is a randomized single-blind, placebo-controlled, Phase 1, single ascending dose (SAD) and repeat dose (RD), safety and tolerability study of AVB-S6-500 in healthy subjects. A SAD portion of the study consists of 4 sequential dose escalation cohorts, whereas RD portion of the study consists of a single cohort receiving 4 weekly doses of AVB-S6-500. In both SAD and RD study arms, subjects are randomized to receive either a study intervention (AVB-S6-500) or matching placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Ascending Dose - AVB-S6-500 | Experimental | Four sequential dose escalation cohorts - patients are randomized either to investigational drug or matching placebo |
|
| Single Ascending Dose - placebo | Placebo Comparator | Four sequential dose escalation cohorts - patients are randomized either to investigational drug or matching placebo |
|
| Repeat Dose - AVB-S6-500 | Experimental | Four single doses of the investigational drug or matching placebo - patients are randomized either to investigational drug or matching placebo |
|
| Repeat Dose - placebo | Placebo Comparator | Four single doses of the investigational drug or matching placebo - patients are randomized either to investigational drug or matching placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AVB-S6-500 | Drug | AVB-S6-500 is an investigational drug. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of AVB-S6-500 - Adverse events | Monitoring of adverse events | Up to 6 weeks |
| Safety and tolerability of AVB-S6-500 - ECG | Monitoring of 12 lead ECGs | Up to 6 weeks |
| Safety and tolerability of AVB-S6-500 -physical examination | Physical examination of body systems | Up to 6 weeks |
| Safety and tolerability of AVB-S6-500 - vital sign | Vital sign measurment | Up to 6 weeks |
| Safety and tolerability of AVB-S6-500 - clinical laboratory assessments | Routine lab hematology, serum chemistry and coagulation | Up to 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| AUC | Area under the curve | Up to 6 weeks |
| Cmax | Maximum observed concentration | Up to 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas C Marbury, MD | Orlando Clinical Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orlando Clinical Research Center | Orlando | Florida | 32809 | United States |
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| ID | Term |
|---|---|
| C000720937 | AVB-500 fusion protein |
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This study has two portions: a single ascending dose (SAD) portion consisting of 4 sequential dose escalation cohorts, and a repeat dose (RD) portion. In both study portions, subjects are randomized to receive either a study intervention (AVB-S6-500) or a placebo.
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| Placebo | Other | Matching placebo |
|
| Ctrough | Serum concentration observed at end of a single dose and observed pre-dose during repeat doses | Up to 6 weeks |
| Tmax | Time to reach maximum observed plasma concentration | Up to 6 weeks |
| λz | Terminal phase elimination rate constant | Up to 6 weeks |
| t1/2 | Terminal half-life | Up to 6 weeks |
| CL | The total body clearance | Up to 6 weeks |
| V | Volume of distribution | Up to 6 weeks |
| Pharmacodynamic parameter | Concentration of the drug target | Up to 6 weeks |