MedTrace Logo

Evaluation of CYT-108, A Recombinant Protease Inhibitor, for Treatment of Mild To Moderate Primary Osteoarthritis Of The Knee

NCT06263270 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2025-12-26

No results posted yet for this study

Summary

The goal of this Phase 1 study is to investigate the safety of CYT-108, our experimental recombinant protease inhibitor drug candidate for osteoarthritis, in a population of patients suffering from osteoarthritis of the knee. The main questions this study aims to answer are:

1. are two doses of CYT-108, delivered 12 weeks apart, safe when injected directly into the joint?
2. does administration of CYT-108 result in a reduction in pain, stiffness, and improvement in daily physical function?

Participants will either receive a placebo (Phosphate Buffer Saline, PBS) or CYT-108, and will be asked to report their pain/stiffness at weeks 1, 4, 8, 12, 16, and 26 (in a physician's office) after the initial injection, using a questionnaire to be provided by the physician. In addition to reporting the magnitude of pain, participants will also be asked about the onset of pain reduction. Researchers will compare the pain/stiffness scores between the CYT-108-treated to placebo-treated groups along the 26 week duration of the study. Participants will also receive blood draws along the course of the study, and researchers will analyze this blood for the presence of cartilage degradation product in attempt to identify "disease modification" (i.e., a reduction in cartilage degradation) in response to CYT-108 treatment.

Conditions

Interventions

BIOLOGICAL

CYT-108, a recombinant protease inhibitor

CYT-108 is a recombinant alpha-2-macroglobulin (A2M) variant engineered with increased potency against A Disintegrin and Metalloproteinase with Thrombospondin motifs (ADAMTS) substrates while possessing strong activity against Matrix Metalloproteinases (MMPs) and serine proteases. This A2M variant was engineered with amino acid modifications to the "bait" region (i.e., protease-binding region) of the A2M protein to make the variant at least two fold more effective in inhibiting ADAMTSs compared to wt-A2M without affecting its inhibitory activity toward other proteases (see Investigator Brochure). CYT-108 is not expected to cure osteoarthritis (OA), but it is expected to be the first treatment to slow disease progression by inhibiting cartilage breakdown, resulting in clinically significant outcomes such as pain reduction and improvement in mobility. This hypothesis is supported by our preliminary findings in multiple safety and efficacy studies conducted in rat and canine models of OA.

OTHER

Phosphate Buffered Saline (PBS)

Phosphate Buffered Saline (PBS)

Sponsors & Collaborators

  • Cytonics Corporation

    lead INDUSTRY

Principal Investigators

  • Joey Bose, MS · Cytonics Corporation

  • Lewis Hanna, PhD · Cytonics Corporation

  • Gaetano Scuderi, MD · Cytonics Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-01
Primary Completion
2025-03-15
Completion
2025-10-10

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

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 NCT06263270 on ClinicalTrials.gov