Study to Evaluate Safety and Activity of TRL1068 in Prosthetic Joint Infections

Summary

TRL1068 is expected to eliminate the pathogen-protecting biofilm in the prosthetic joint and surrounding tissue, thus making these pathogens substantially more susceptible to established antibiotic treatment regimens. This initial study is designed to assess overall safety and pharmacokinetics (PK) of TRL1068. The overall goal of the development program is to demonstrate that TRL1068 can facilitate effectiveness of a single stage joint replacement or preservation of the original infected prosthetic joint in a substantial proportion of patients with PJI.

Conditions

• Prosthetic Joint Infection

Interventions

DRUG

TRL1068, a human monoclonal antibody

A human IgG1κ (G1m1,17 (z,a); Km3 allotype) monoclonal antibody

Sponsors & Collaborators

• University of California, Los Angeles

  collaborator OTHER

• Biomedical Advanced Research and Development Authority

  collaborator FED

• Wellcome Trust

  collaborator OTHER

• Sinai Hospital of Baltimore

  collaborator OTHER

• Gulfcoast Research Institute

  collaborator UNKNOWN

• Phoenix Clinical Research

  collaborator OTHER

• University of Florida

  collaborator OTHER

• University of Alabama at Birmingham

  collaborator OTHER

• The Methodist Hospital Research Institute

  collaborator OTHER

• University of Virginia

  collaborator OTHER

• University of Southern California

  collaborator OTHER

• Trellis Bioscience LLC

  lead INDUSTRY

Principal Investigators

• Nicholas Bernthal, MD · University of California, Los Angeles

• Janet Conway, MD · Sinai Hospital of Baltimore

• Edward Stolarski, MD · Gulfcoast Research Institute

• Richard Berkowitz, MD · Phoenix Clinical Research

• Luis Pulido, MD · University of Florida

• Sameer Naranje, MD · University of Alabama at Birmingham

• Stephen Incavo, MD · The Methodist Hospital Research Institute

• Ian Duensing, MD · UVA

• Daniel Oakes, MD · University of Southern California

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-02-08

Primary Completion

2024-03-13

Completion

2024-03-13

FDA Drug

Yes

Countries

• United States

Study Locations