Osteoarthritis of the KneePhase 1NCT07338266
Study to Assess the Safety and Pharmacokinetics of AVD275 Injection in Patients With Osteoarthritis of the Knee
A Phase 1 study testing AVD275 Intra-articular Injection in people with Osteoarthritis of the Knee, run by Avidence Therapeutics at 1 site in Australia.
Trial summary
This study aims to understand the safety, drug concentration and distribution of an intra-articular injectable formulation of celecoxib, AVD275, in patients with knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Osteoarthritis of the Knee
- What is being tested?
- AVD275 Intra-articular Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteAustralia
- Study dates
- 22 Jan 2026to May 2027
- Phase
- Phase 1
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written consent to participate in the study; Willingness and ability to comply with the study procedures, visit schedules and follow verbal and written instructions
- Male or female: 20 years to 75 years of age
- Symptoms associated with OA of the knee for ≥6 months prior to screening (patient reported is acceptable); Knee OA may be unilateral or bilateral
- Currently meets ACR Criteria (clinical and radiological) for OA as follows:
- Knee pain
- At least one of the following:
Show all 13Show fewer
- Age > 50 years
- Stiffness < 30 minutes
- Crepitus
- Osteophytes
- Kellgren-Lawrence (K-L) Grade 1-4 in the index knee based on X-ray performed during screening (locally read) within 6 months from screening
- Body mass index (BMI) ≤ 40 kg/m2
- Ambulatory and in good general health
Who cannot join
- Any condition that could confound the patient's assessment of index knee pain in judgement of the investigator (for example, peri-articular pain of any cause or secondary arthritis that involves the index knee, joint dysplasia, aseptic osteonecrosis, acromegaly, Paget's disease, Ehlers-Danlos Syndrome, Gaucher's disease, Stickler's syndrome, hemophilia, hemochromatosis, or neuropathic arthropathy, radicular lower back pain and hip pain that is referred to the knee that could cause misclassification); Other chronic pain anywhere in the body that confounds assessment of knee or that requires the use of celecoxib
- Malalignment of greater than 10 degrees in the femorotibial axis of the index knee on standing; Unstable joint (such as tornanterior cruciate ligament) or traumatic knee injury to the index knee (such as meniscal root tear) within 12 months of screening
- Fibromyalgia, Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, reactive arthritis, arthritis associated with inflammatory bowel disease, crystal disease of the index knee (e.g. gout or calcium pyrophosphate deposition disease), rapidly progressive osteoarthritis (defined as joint space narrowing > 1.2 mm/year), sarcoidosis or amyloidosis
- Effusion at screening that likely requires joint aspiration for symptom relief from day 2 to day 83 during the study, as indicated by at least four joint drainages in the past year
- Intra-articular corticosteroids or intra-articular nonsteroidal antiinflammatory drugs (NSAIDs) (investigational or marketed) in the index knee within 2 months of screening; Intra-articular hyaluronic acid (investigational or marketed) in the index knee within 3 months of screening; Intra-articular Zilretta within 3 months of screening
- Intramuscular or oral corticosteroids within 1 month of screening
Show all 27Show fewer
- Patients who received opioids (excluding tramadol and tapentadol) within 2 weeks of screening
- Any other investigational drug/biologic use within 3 months of screening
- Prior diagnostic arthroscopy to the index knee within 3 months of screening; Prior arthroscopic or open surgery of the index knee (including microfracture and meniscectomy) within 6 months of screening；Prior regenerative joint procedures on the index knee, including, but not limited to, stem cells transplantation, autologous chondrocyte transplantation, or mosaicplasty within 12 months of screening; History of total or partial knee arthroplasty in the index knee
- Planned/anticipated surgery of the index knee, any other surgery, or hospitalization during the study period
- Known hypersensitivity to any form of NSAIDs (including celecoxib), sulfonamide-containing drugs, carboxymethyl cellulose, polysorbate 80 or lidocaine; History of severe allergic reactions
- Active or history of malignancy within the past 3 years, with the exception of resected basal cell carcinoma, squamous cell carcinoma of the knee, or effectively managed cervical carcinoma
- Known active or quiescent systemic fungal, bacterial (including tuberculosis), viral or parasitic infections (including HIV, hepatitis B or C viruses), or ocular herpes simplex; Any infection requiring intravenous antibiotics within 2 months of screening or oral antibiotics within 2 weeks of screening; History of infection in the index knee within 12 months of screening; History of osteomyelitis
- Any clinically significant laboratory parameters or ECG abnormality as judged by the investigator
- Uncontrolled diabetes as indicated by a hemoglobin A1c of >7.5% at screening
- History of atherosclerotic cardiovascular disease (ASCVD) defined as prior myocardial infarction, stroke (ischaemic or haemorrhagic), transient ischemic attack, coronary revascularization (e.g., PCI, CABG), peripheral artery disease, or heart failure (NYHA Class II or higher) in the past three years;
- OR a calculated 10-year ASCVD risk ≥10% based on age, sex, race, total/HDL cholesterol, systolic blood pressure, diabetes, smoking status;
- OR current use of dual antiplatelet therapy, chronic anticoagulation (e.g., warfarin, direct oral anticoagulants), or high-dose aspirin (>300 mg/day)
- Abnormal liver function with AST or ALT > 2 upper limit of normal (ULN) at screening
- Abnormal kidney function with eGFR < 45 mL/min/1.73m2 at screening
- Platelet count outside normal range at screening
- WBC count < 3500 cells/mm3 or >20000 cells/mm3 at screening
- Active uncontrolled psychiatric disorder including psychosis (e.g. schizophrenia), bipolar disorder, uncontrolled anxiety disorder and major depressive disorder
- Positive drug screen (opiates, amphetamines, cocaine metabolites, benzodiazepines, cannabinoids); Active substance abuse (drugs or alcohol), history of chronic substance abuse within the past year, or prior chronic substance abuse judged by the investigator as likely to recur during the study
- Skin breakdown at the knee where the injection would take place; Any skin condition and/or tattoo that may interfere with the evaluation of safety at the injection site
- Women who are pregnant or nursing; Women of child-bearing potential (not surgically sterile or post-menopausal for at least 1 year as documented in medical history) not using a highly effective method of contraception (abstinence; oral, injected or implanted hormonal methods of contraception; intrauterine device or intrauterine system; condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/cream/suppository; or male sterilization (vasectomy for at least 3 months))
- Any other clinically significant acute or chronic medical conditions (e.g. bleeding disorder) that, in the judgement of the investigator, would preclude the use of an intra-articular NSAID or that could compromise patient safety, limit the patient's ability to complete the study, and/or compromise the objectives of the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Cognivus Research Group
Wahroonga, New South Wales, 2076
Amir Papan, +61 (02) 9687 9633, amir.papan@cognivus.com.au
About this study
Official title: A Single Ascending Dose Study to Assess the Safety and Pharmacokinetics of Intra-articular AVD275 Injection in Patients With Osteoarthritis of the Knee
This study aims to understand the safety, drug concentration and distribution of an intra-articular injectable formulation of celecoxib, AVD275, in patients with knee osteoarthritis. One single injection at three different doses of the drug will be studied in a sequential order, and each participant will be monitored for 24 weeks over ten clinical visits.
- Conditions
- Osteoarthritis of the Knee
- Being tested
- AVD275 Intra-articular Injection
- Keywords
- Osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVD275 Intra-articular InjectionDrug
A long-acting formulation of celecoxib
| Study group | Role | What they receive |
|---|---|---|
| Low Dose Arm | Experimental | One low dose of AVD275 is injected to the osteoarthritic knee joint Receives: Drug: AVD275 Intra-articular Injection |
| Middle Dose Arm | Experimental | One middle dose of AVD275 is injected to the osteoarthritic knee joint Receives: Drug: AVD275 Intra-articular Injection |
| High Dose Arm | Experimental | One high dose of AVD275 is injected to the osteoarthritic knee joint Receives: Drug: AVD275 Intra-articular Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of treatment emergent adverse events
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start22 Jan 2026
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of the KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Avidence Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ang Li, Study director, Avidence Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07338266
- Sponsor's protocol ID
- AVD275CLIN-2025-001
- Status last verified
- Oct 2026
- First submitted
- 3 Jan 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Ascending Dose Study to Assess the Safety and Pharmacokinetics of Intra-articular AVD275 Injection in Patients With Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT07338266
- Acronym / sponsor ID
- AVD275CLIN-2025-001
- Conditions
- Osteoarthritis of the Knee
- Keywords
- Osteoarthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Avidence TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 22 Jan 2026 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 13 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to understand the safety, drug concentration and distribution of an intra-articular injectable formulation of celecoxib, AVD275, in patients with knee osteoarthritis. One single injection at three different doses of the drug will be studied in a sequential order, and each participant will be monitored for 24 weeks over ten clinical visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low Dose Arm | Experimental | Drug: AVD275 Intra-articular InjectionOne low dose of AVD275 is injected to the osteoarthritic knee joint |
| Middle Dose Arm | Experimental | Drug: AVD275 Intra-articular InjectionOne middle dose of AVD275 is injected to the osteoarthritic knee joint |
| High Dose Arm | Experimental | Drug: AVD275 Intra-articular InjectionOne high dose of AVD275 is injected to the osteoarthritic knee joint |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Written consent to participate in the study; Willingness and ability to comply with the study procedures, visit schedules and follow verbal and written instructions
- Male or female: 20 years to 75 years of age
- Symptoms associated with OA of the knee for ≥6 months prior to screening (patient reported is acceptable); Knee OA may be unilateral or bilateral
- Currently meets ACR Criteria (clinical and radiological) for OA as follows:
- Kellgren-Lawrence (K-L) Grade 1-4 in the index knee based on X-ray performed during screening (locally read) within 6 months from screening
Key exclusion criteria (27 listed)
- Any condition that could confound the patient's assessment of index knee pain in judgement of the investigator (for example, peri-articular pain of any cause or secondary arthritis that involves the index knee, joint dysplasia, aseptic osteonecrosis, acromegaly, Paget's disease, Ehlers-Danlos Syndrome, Gaucher's disease, Stickler's syndrome, hemophilia, hemochromatosis, or neuropathic arthropathy, radicular lower back pain and hip pain that is referred to the knee that could cause misclassification); Other chronic pain anywhere in the body that confounds assessment of knee or that requires the use of celecoxib
- Malalignment of greater than 10 degrees in the femorotibial axis of the index knee on standing; Unstable joint (such as tornanterior cruciate ligament) or traumatic knee injury to the index knee (such as meniscal root tear) within 12 months of screening
- Fibromyalgia, Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, reactive arthritis, arthritis associated with inflammatory bowel disease, crystal disease of the index knee (e.g. gout or calcium pyrophosphate deposition disease), rapidly progressive osteoarthritis (defined as joint space narrowing > 1.2 mm/year), sarcoidosis or amyloidosis
- Effusion at screening that likely requires joint aspiration for symptom relief from day 2 to day 83 during the study, as indicated by at least four joint drainages in the past year
- Intra-articular corticosteroids or intra-articular nonsteroidal antiinflammatory drugs (NSAIDs) (investigational or marketed) in the index knee within 2 months of screening; Intra-articular hyaluronic acid (investigational or marketed) in the index knee within 3 months of screening; Intra-articular Zilretta within 3 months of screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AVD275 Intra-articular InjectionA long-acting formulation of celecoxib | Drug | High Dose Arm, Low Dose Arm, Middle Dose Arm |
Primary outcome
Frequency of treatment emergent adverse events
Time frame: 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Osteoarthritis of the Knee
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ang Li study director
Avidence Therapeutics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AVD275 Intra-articular Injection in people with Osteoarthritis of the Knee, run by Avidence Therapeutics 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 13 inclusion and 27 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: looking for participants now, as of the sponsor's last update on 20 Oct 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Ang Li (413-652-4949, ang.li@avidenceinc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of treatment emergent adverse events (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Oct 2026.