drugset / Trial / NCT03401528

A Phase 1 AVB-S6-500 Safety and Tolerability Study

NCT03401528

Phase 1 Completed 43 enrolled Aravive, Inc.
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

EvaluationDrugModalityDoseRoute
Subject Batiraxcept Protein / enzyme biologic Intravenous

Indications

No indication recorded.