NCT03401528

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

A Single-blind, Randomized, Placebo-controlled, Phase 1, Single Ascending-dose and Repeat-dose, Safety and Tolerability Study of Intravenous AVB-S6-500 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Aravive, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	AVB-S6-500	AVB-S6-500 is an investigational drug.
OTHER	Placebo	Matching placebo

Timeline

• Start date: 2018-01-31
• Primary completion: 2018-06-20
• Completion: 2018-07-31
• First posted: 2018-01-17
• Last updated: 2018-08-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study