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Safety Tolerability, and PK of RYI-018 After Repeat Dosing in Subjects With Non-Alcoholic Fatty Liver Disease (NAFLD)

NCT03261739 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2019-03-14

No results posted yet for this study

Summary

BRB-018-001 is a multicenter, adaptive design, randomized, parallel group study to evaluate the safety, tolerability, and PK of repeat IV doses of RYI-018 in subjects with NAFLD.

Conditions

  • NAFLD

Interventions

BIOLOGICAL

RYI-018

Anti-CB1 monoclonal antibody

BIOLOGICAL

Placebo

Placebo

Sponsors & Collaborators

  • ProSciento, Inc.

    collaborator INDUSTRY

  • Perspectum

    collaborator INDUSTRY

  • Bird Rock Bio, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-28
Primary Completion
2018-08-24
Completion
2018-08-24
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada

Study Locations

More Related Trials

Entities

Drugs

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 NCT03261739 on ClinicalTrials.gov