Study to Assess the Safety and Pharmacokinetics of AVD275 Injection in Patients With Osteoarthritis of the Knee

NCT07338266 | Recruiting Phase 1 DMC

• 1 other identifier: AVD275CLIN-2025-001
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Frequency of treatment emergent adverse events

  24 weeks

Study Arms (3)

Low Dose Arm

EXPERIMENTAL

One low dose of AVD275 is injected to the osteoarthritic knee joint

Drug: AVD275 Intra-articular Injection

Middle Dose Arm

EXPERIMENTAL

One middle dose of AVD275 is injected to the osteoarthritic knee joint

Drug: AVD275 Intra-articular Injection

High Dose Arm

EXPERIMENTAL

One high dose of AVD275 is injected to the osteoarthritic knee joint

Drug: AVD275 Intra-articular Injection

Interventions

AVD275 Intra-articular Injection DRUG

A long-acting formulation of celecoxib

High Dose Arm; Low Dose Arm; Middle Dose Arm

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Avidence Therapeutics: lead

Study Sites (1)

Cognivus Research Group

Wahroonga, New South Wales, 2076, Australia

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Ang Li

  Avidence Therapeutics

  STUDY DIRECTOR

Central Study Contacts

Ang Li

CONTACT

413-652-4949; ang.li@avidenceinc.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2026
• First Posted: January 13, 2026
• Study Start: January 22, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 31, 2026

Record last verified: 2026-03

Locations

AU (1)