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

NCT03401528 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2018-08-09

No results posted yet for this study

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

DRUG

AVB-S6-500

AVB-S6-500 is an investigational drug.

OTHER

Placebo

Matching placebo

Sponsors & Collaborators

  • Aravive, Inc.

    lead INDUSTRY

Principal Investigators

  • Thomas C Marbury, MD · Orlando Clinical Research Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-31
Primary Completion
2018-06-20
Completion
2018-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03401528 on ClinicalTrials.gov