Lubricin-inspired Osteoarthritis Treatment: a Unique Solution

NCT07611708 | Not Yet Recruiting

• 1 other identifier: PC2601
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This goal of this open label study is to evaluate the safety and tolerability of a single intra-articular administration of ABR1 in adults with knee osteoarthritis with a KL grade from 2 to 4. The primary questions it aims to answer are:

1. 1.Is ABR1 safe to use as an intraarticular injection for participants with knee osteoarthritis?
2. 2.What medical problems do participants have after receiving a single injection of ABR1?
3. 3.Keep a stable pain treatment regimen
4. 4.Visit the clinic at 1 week, 4 weeks, 8 weeks, and 12 weeks post injection
5. 5.Keep a diary of their symptoms and number of times they use a rescue medication for their knee pain.

Conditions

Osteo Arthritis of the Knee

Keywords

knee pain; intra articular; lubrication

Outcome Measures

Primary Outcomes (1)

• Number of adverse events

  Incidence of treatment-emergent adverse events (TEAEs) through Week 12

  from the day receiving study intervention (day 0) to 12 weeks after study intervention

Study Arms (1)

Received ABR1

EXPERIMENTAL

Received a single dose of ABR1

Device: ABR1

Interventions

ABR1 DEVICE

Received a single dose of ABR1

Received ABR1

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female at least 40years of age
• Knee OA with Kellgren-Lawrence (KL) Grade 2 to 4 of the target knee on X-ray
• Inadequate pain relief with 1st line treatment, consisting of any of the following
• conservative non-pharmacological treatment AND/OR
• stable dose NSAIDs for at least the past 30 days OR
• use of NSAID treatment is contraindicated
• Target knee pain on most days (at least 15 days per month in the preceding month)
• Symptomatic knee OA with moderate to severe pain (NRS ≥4 and \<9 on Numeric Rating Scale (NRS) with target knee significantly worse than the other knee with a minimum difference of 2-point between knees.
• Possess cognitive and language ability to complete informed consent and questionnaires
• Willingness to follow protocol instructions and maintain appointment schedule of the study
• Willingness to maintain their existing stable regimen (defined as the same regimen for at least the past 30 days) of complementary and non-pharmacological knee OA treatments for trial duration (if any)
• If participant is taking a stable regimen of NSAIDs - they are willing to maintain their existing stable regimen (defined as taking the same dose for at least the past 30 days) of NSAIDs and not anticipate to change for the duration of the study.
• Willingness to stop any 'as needed' (PRN) NSAIDs or paracetamol or opioids (except for protocol-permitted rescue pain medication) for the duration of the trial
• Willingness to stop taking any rescue pain meds 24 hours prior to scheduled follow up clinic visits (except for their stable NSAIDs therapy)

You may not qualify if:

• Pregnant or lactating
• Other significant knee pathologies of target knee from medical history or radiographic method(s)
• Severe malalignment \> 10 degree in the target knee (either varus or valgus) measured using standardized knee x-ray at screening or based on previous medical records
• Severe inflammatory arthritis or other joint disease with warm, red, and swollen knee in the target knee
• History of knee surgery or significant knee trauma of target knee in the past 12 months
• Received intraarticular injection in the targeted knee joint within the past 6 months
• Knee surgery or intraarticular injection in the target knee planned in the next 8 months
• Allergy to rescue pain medication (paracetamol)
• Unstable/ poorly controlled coagulopathy\[CH1.1\]\[LC1.2\]
• Severe anxiety, depression or psychiatric disorder based on self -reported medical history
• Chronic pain conditions other than knee OA (e.g. cancer, fibromyalgia, pain due to hip OA, etc.) which may interfere with the outcomes of the study, at the discretion of the investigator
• History of or current substance abuse, self-reported
• Significant systemic medical comorbidities, e.g. uncontrolled diabetes or hypertension, immunocompromised, cancer, severe cardiovascular disease, neuropathic pain/disorder, etc.
• ModifiedPainDETECT Questionnaire (mPDQ) \>18
• Current use of any non-opioids centrally acting analgesics including gabapentin, pregabalin, duloxetine, tricyclic antidepressants (e.g. amitriptyline) for pain management within 12 weeks prior to screening.

Sponsors & Collaborators

• Pleryon Therapeutics (Hangzhou) Limited: lead

Study Sites (1)

Royal North Shore Hospital

Sydney, New South Wales, 2065, Australia

Location

Related Publications (1)

• Sun Z, Feeney E, Guan Y, Cook SG, Gourdon D, Bonassar LJ, Putnam D. Boundary mode lubrication of articular cartilage with a biomimetic diblock copolymer. Proc Natl Acad Sci U S A. 2019 Jun 18;116(25):12437-12441. doi: 10.1073/pnas.1900716116. Epub 2019 Jun 4.

  PMID: 31164421 BACKGROUND

Study Officials

• Charis Lau, PharmD, OD, MBA

  Pleryon Therapeutics Limited

  STUDY CHAIR

• David Hunter, MD

  Royal North Shore Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Coordinator

CONTACT

0295625360; lotus.study@sydney.edu.au

Camilla Herberstein

CONTACT

0295625360; camilla.herberstein@sydney.edu.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Study model is a sterile, transparent solution provided in a pre-filled syringe for intra-articular injection

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: May 28, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)