A Phase 1/2a Study to Evaluate Single Intraarticular Injections of 3 Dose Levels of SYN321 and Pl… (NCT06989645) | Clinical Trial Compass
CompletedPhase 1/2
A Phase 1/2a Study to Evaluate Single Intraarticular Injections of 3 Dose Levels of SYN321 and Placebo in Patients With Symptomatic Knee Osteoarthritis
Sweden35 participantsStarted 2025-08-19
Plain-language summary
This is a, phase 1/2a trial, to assess the safety, tolerability, systemic exposure as well as preliminary efficacy following a single intra-articular injection of 3 dose levels of SYN321 in patients with symptomatic knee osteoarthritis (KOA).
Who can participate
Age range
40 Years – 79 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Willing and able to give electronically informed consent for participation in the trial and willing and able to participate in all procedures and follow-up evaluations necessary to complete the trial.
. Male or female patient clinically diagnosed with KOA, no later than 3 months prior to Visit 1. The KOA diagnosis should be confirmed in the patient's medical record.
. Dominant pain in one knee due to KOA with weight bearing pain between 4 and 8 inclusive on the NRS scale (0-10) at the time of inclusion (checked at screening \[Visit 1\] and confirmed at Visit 2, pain during the last 7 days).
. Age 40 to 79 years, inclusive at the time of Visit 1.
. Body mass index (BMI) ≥ 18.5 and \< 35.0 kg/m2.
. Patients without abnormal clinically significant medical history, physical findings, vital signs, hypotension, cardiovascular disease, ECG, and laboratory values at the time of the screening visit, as judged by the Investigator. (Discussion is encouraged between the Investigator and the Medical Monitor regarding the clinical relevance of any abnormal laboratory value during the pre-dose period.)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence and intensity of adverse events
Timeframe: From IMP injection (day 1) until end of trial visit (day 56)
2
Clinically significant changes in ECG
Timeframe: From screening until end of trial visit (day 56)
3
Clinically significant changes in blood pressure
Timeframe: From screening until end of trial visit (day 56)
4
Clinically significant changes in heart rate
Timeframe: From screening until end of trial visit (day 56)
5
Clinically significant changes in body temperature
Timeframe: From screening until end of trial visit (day 56)
6
Clinically significant changes in Clinical Laboratory Profile
Timeframe: From screening until end of trial visit (day 56)
7
Clinically significant changes in urine analysis
Timeframe: From screening until end of trial visit (day 56)
. Patient is willing to discontinue all pain medication (COX-2 inhibitors, NSAIDs, and opioid analgesics) at least 10 days before trial drug administration (prior to Day 1) and for the trial duration. Paracetamol will be allowed as rescue medication up to max 4000 mg/day (except for 24 hours prior to visit to the trial site).
. Patient agrees not to take additional knee symptom-modifying drugs (e.g., glucosamine, collagen, HA) at least 10 days before trial drug administration (prior to Day 1) and for the trial duration.
Exclusion criteria
. History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the patient at risk because of participation in the trial, or influence the results or the patient's ability to participate in the trial.
. Previous IA fracture of the knee.
. Patient has rheumatoid arthritis, psoriatic arthritis, or has been diagnosed with any other disorders that is the primary source of their knee pain, including but not limited to: osteonecrosis, radiculopathy, bursitis, tendinitis, tumor, cancer.
. IA injections of steroids or HA or other invasive procedure (e.g., arthroscopy, arthrography, surgery) in the knee within 3 months prior to screening.
. Conditions or medications that could confound the assessment of pain, as judged by the Investigator.
. Conditions that could be adversely affected by an IA injection (e.g., eczema, skin infection, high bleeding risk etc.), as judged by the Investigator.
. Any clinically significant illness (except KOA), medical/surgical procedure, or trauma within 4 weeks of the administration of IMP.
. Malignancy within the past 5 years, with the exception of in situ removal of basal cell carcinoma.
8
Clinically significant changes in Physical Examination
Timeframe: From screening until end of trial visit (day 56)
9
Clinically significant changes of local tolerability reactions
Timeframe: From screening until end of trial visit (day 56)