Actively Recruiting
Study to Assess the Safety and Pharmacokinetics of AVD275 Injection in Patients With Osteoarthritis of the Knee
Led by Avidence Therapeutics · Updated on 2026-03-31
15
Participants Needed
1
Research Sites
44 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Study to Assess the Safety and Pharmacokinetics of AVD275 Injection in Patients With Osteoarthritis of the Knee
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written consent and ability to follow study procedures and visits
- Male or female aged 20 to 75 years
- Symptoms of osteoarthritis of the knee for at least 6 months
- Meets American College of Rheumatology clinical and radiological criteria for knee osteoarthritis
- Kellgren-Lawrence Grade 1-4 in the index knee by X-ray within 6 months
- Body mass index of 40 kg/m2 or less
- Ambulatory and in good general health
You will not qualify if you...
- Conditions affecting accurate knee pain assessment or secondary arthritis affecting the index knee
- Knee malalignment over 10 degrees or unstable joint or traumatic injury within 12 months
- Other inflammatory or crystal arthritis or rapidly progressive osteoarthritis
- Effusion likely requiring joint drainage from day 2 to 83 during the study
- Recent intra-articular corticosteroids or NSAIDs within 2-3 months
- Recent intramuscular or oral corticosteroids within 1 month
- Opioid use (excluding tramadol and tapentadol) within 2 weeks
- Use of other investigational drugs within 3 months
- Recent arthroscopy or knee surgery within 3-12 months
- Planned surgery or hospitalization during the study
- Allergies to NSAIDs, sulfonamides, or study drug components
- Recent or active malignancy except certain treated skin or cervical cancers
- Active or recent infections including HIV, hepatitis, or osteomyelitis
- Significant lab or ECG abnormalities
- Uncontrolled diabetes (HbA1c >7.5%)
- Recent cardiovascular disease or high cardiovascular risk
- Abnormal liver or kidney function
- Abnormal blood counts
- Untreated psychiatric disorders
- Positive drug screen or substance abuse history
- Skin conditions at injection site
- Pregnant or nursing women or women not using effective contraception
- Other medical conditions that could affect safety or study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cognivus Research Group
Wahroonga, New South Wales, Australia, 2076
Actively Recruiting
Research Team
A
Ang Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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