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Osteo Arthritis of the KneeLOTUSNCT07611708

Lubricin-inspired Osteoarthritis Treatment: a Unique Solution

A study testing ABR1 in people with Osteo Arthritis of the Knee, run by Pleryon Therapeutics (Hangzhou) Limited at 1 site in Australia.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Osteo Arthritis of the Knee
What is being tested?
ABR1
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteAustralia
Study dates
Aug 2026to Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 14Show fewer
  • 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)

Who cannot join

  • 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
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  • 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.
  • Started taking oral or injectable GLP-1 products in the past 6 months as new regimen. Current use of a GLP-1 product is permitted if the participant has been on the product for > 6 months and plans to continue the product at its current stable dose for the duration of the trial.
  • Started taking another concomitant medication within the past 12 weeks or changed dose of a concomitant medication within the past 12 weeks which could, in the opinion of the Principal Investigator or delegate, impact the participant's safety on the trial or the reliability of the outcome assessments.
  • Participate in another clinical trial and received study intervention currently or in the past 3 months

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Study Coordinator contact

0295625360

lotus.study@sydney.edu.au

Camilla Herberstein contact

0295625360

camilla.herberstein@sydney.edu.au

Australia1 site

  • Royal North Shore Hospital

    Sydney, New South Wales, 2065

    LOTUS Study Coordinator, 02 95625360, lotus.study@sydney.edu.au

Other trials in Australia

About this study

Official title: First in Human Safety Evaluation of a Novel Polymer for Knee Osteoarthritis

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. Is ABR1 safe to use as an intraarticular injection for participants with knee osteoarthritis?
  2. What medical problems do participants have after receiving a single injection of ABR1?
Read more

Participants will receive a single injection of ABR1 to the knee with osteoarthritis. Participants will

  1. Keep a stable pain treatment regimen
  2. Visit the clinic at 1 week, 4 weeks, 8 weeks, and 12 weeks post injection
  3. Keep a diary of their symptoms and number of times they use a rescue medication for their knee pain.
Read the detailed description

This first-in-human study is a single-site, open-label, single-arm investigation in adults with knee osteoarthritis from KL grade 2 to 4 evaluating safety and tolerability of a single, ultrasound-guided intra-articular injection of ABR1, while also observing any signals of symptom improvement over 24 weeks post-injection. All enrolled participants will receive a single administration of ABR1 intraarticularly in the target knee and will be followed per protocol for safety monitoring and clinical assessments. Participants should continue to take their medications for pre-existing medical conditions as usual during the trial. Participants will be advised that they may use study allowed rescue medication to treat worsening pain. Participants will record any rescue medication use in their Participant Diary.

Researchers will assess the incidence of adverse events, its relatedness to the device, and the incidence of any treatment-related serious adverse events through Week 12. Patient reported outcomes related to knee osteoarthritis pain will be observed up to Week 24 post injection.

Being tested
ABR1
Keywords
knee pain, intra articular, lubrication

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ABR1Device

    Received a single dose of ABR1

Study groups in NCT07611708
Study groupRoleWhat they receive
Received ABR1ExperimentalReceived a single dose of ABR1
Receives: Device: ABR1

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of adverse events

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 May 2026
  2. Study startAug 2026 (estimated)
  3. Primary completionJun 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Study model is a sterile, transparent solution provided in a pre-filled syringe for intra-articular injection
Masking
None (open label)
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07611708
Sponsor's protocol ID
PC2601
Acronym
LOTUS
Status last verified
May 2026
First submitted
21 May 2026
Last updated
29 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 31164421

Questions about this trial

What is this clinical trial studying?

A study testing ABR1 in people with Osteo Arthritis of the Knee, run by Pleryon Therapeutics (Hangzhou) Limited at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Study Coordinator (0295625360, lotus.study@sydney.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of adverse events (time frame: from the day receiving study intervention (day 0) to 12 weeks after study intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07611708, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.

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