drugset / Trial / NCT03401528
A Phase 1 AVB-S6-500 Safety and Tolerability Study
RandomizedSequentialSingle-blindTreatment
Summary
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.
Timeline
- Start
- 2018-01-31
- Primary completion
- 2018-06-20
- Completion
- 2018-07-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Batiraxcept | Protein / enzyme biologic | — | Intravenous |
Indications
No indication recorded.