Osteoarthritis of KneePhase 1/2NCT06989645
A Phase 1/2a Study to Evaluate Single Intraarticular Injections of 3 Dose Levels of SYN321 and Placebo in Patients With Symptomatic Knee Osteoarthritis
A Phase 1/2 study testing SYN321 in people with Osteoarthritis of Knee, run by Synartro AB at 1 site in Sweden.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 79 years
- Conditions the study is for
- Osteoarthritis of Knee
- What is being tested?
- SYN321
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteSweden
- Study dates
- 19 Aug 2025to 2 Mar 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.)
Show all 16Show fewer
- 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.
- WOCBP must practice abstinence heterosexual intercourse (only allowed when this is the preferred and usual lifestyle of the patient) or agree to use a highly effective method of contraception with a failure rate of < 1 % to prevent pregnancy from that least 2 weeks prior to the administration of IMP to 4 weeks after the last administration of IMP. In addition, any male partner of a female patient must, unless he has undergone vasectomy, agree to use a condom from the first administration of IMP until 4 weeks after the last administration of IMP.
- The following are considered highly effective methods of contraception:
- combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal),
- progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable),
- intrauterine device [IUD]or intrauterine hormone-releasing system [IUS]). WOCBP must refrain from donating eggs from the first IMP administration until 3 months after the last IMP administration.
- Women of non-childbearing potential are pre-menopausal females who have undergone any of the following surgical procedures; hysterectomy, bilateral salpingectomy, or bilateral oophorectomy, or who are post-menopausal defined as 12 months of amenorrhea (in questionable cases a blood sample with detection of follicle stimulating hormone [FSH] >25 IU/L is confirmatory).
- Male patients must be willing to use condom or be vasectomized or practice sexual abstinence from heterosexual intercourse (only allowed when this is the preferred and usual lifestyle of the patient) to prevent pregnancy and drug exposure of a partner and refrain from donating sperm from the first administration of IMP until 3 months after the last administration of IMP. Any female partner of a non-vasectomized male patient who is of childbearing potential must use contraceptive methods with a failure rate of < 1% to prevent pregnancy (see above) from at least 2 weeks prior to the first administration of IMP to 4 weeks after the last administration of IMP.
- Patients without contraindications for treatment with diclofenac.
Who cannot join
- 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.
Show all 28Show fewer
- 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.
- Any planned major surgery within the duration of the trial.
- Patients who are pregnant, currently breastfeeding, or intend to become pregnant during the course of the trial.
- Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibodies and/or human immunodeficiency virus (HIV).
- After 10 minutes supine rest at the time of screening, any vital signs outside the following ranges:
- Systolic blood pressure (BP): <90 or >160 mmHg, or
- Diastolic blood pressure <50 or >95 mmHg, or
- Pulse <40 or >90 bpm
- Prolonged QTcF (> 450 ms), cardiac arrhythmias or any clinically significant abnormalities in the resting ECG at the time of screening, as judged by the Investigator.
- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator, or history of hypersensitivity to drugs with a similar chemical structure or class to SYN321, including disinfectants and adhesives or hypersensitivity to acetylsalicylic acid.
- History of asthma, angioedema, urticaria or acute rhinitis induced by NSAID, including acetylsalicylic acid.
- Regular use of any prescribed or non-prescribed medications, including but not limited to antacids, analgesics, herbal remedies, vitamins and minerals, within 10 days prior to the first administration of IMP, as well as nasal decongestants without cortisone, antihistamine, or anticholinergics for a maximum of 10 days, at the discretion of the Investigator.
- Patient has taken pain medication or has received pain medicine other than paracetamol for conditions unrelated to KOA of the index knee within 10 days prior to the injection.
- Planned treatment or treatment with another investigational drug within 3 months prior to Day 1. Patients consented and screened but not dosed in previous phase 1 studies will not be excluded.
- Current smokers or users of nicotine products. Irregular use of nicotine (e.g., smoking, snuffing, chewing tobacco) less than 3 times/week before the screening visit will be allowed.
- Positive screen for drugs of abuse or alcohol at screening. Positive results that are expected given the patient's medical history and prescribed medications can be disregarded as judged by the Investigator.
- History of or current alcohol abuse or excessive intake of alcohol, as judged by the Investigator.
- History of or current drug abuse, as judged by the Investigator.
- History of or current use of anabolic steroids, as judged by the Investigator.
- Plasma donation within 1 month of screening or blood donation (or corresponding blood loss) during the last 3 months prior to screening.
- The Investigator considers the patient unlikely to comply with trial procedures, restrictions, and requirements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Double-blinded, Randomized, Placebo-controlled Phase 1/2a Study to Assess Safety, Tolerability, Systemic Exposure, and Preliminary Efficacy of Single Intraarticular Injections of 3 Dose Levels of SYN321 and Placebo in Patients With Symptomatic Knee Osteoarthritis
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).
Read the detailed description
Participants will receive a single intra-articular injection of SYN321 or placebo. 4 sequential cohorts are planned. The fourth cohort will repeat one of the previously 3 administered dose levels. The first 2 participants in each cohort will be dosed in a sentinel fashion. The participants will be followed for 56 days.
- Conditions
- Osteoarthritis of Knee
- Being tested
- SYN321, Placebo
- Keywords
- knee osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYN321Drug
Intra-articular
PlaceboDrug
Also called NaCl 9 mg/mL
Intra-articular
| Study group | Role | What they receive |
|---|---|---|
| SYN321, dose level 1 | Active comparator | Cohort 1: 6 participants recieves SYN321. Receives: Drug: SYN321 |
| SYN321, dose level 2 | Active comparator | Cohort 2: 6 participants recieves SYN321. Receives: Drug: SYN321 |
| SYN321, dose level 3 | Active comparator | Cohort 3: 6 participants recieves SYN321. Receives: Drug: SYN321 |
| SYN321, dose level 1,2 or 3 | Active comparator | Cohort 4: 6 participants recieves SYN321. Receives: Drug: SYN321 |
| Placebo | Placebo comparator | Placebo: 2 participants each from cohort 1, 2 and 3, and 6 participants from cohort 4 receive placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and intensity of adverse events
Frequency, intensity and seriousness of adverse events (AEs) will be assesed. The intensity grades is defined as mild, moderate or severe. AEs will be assessed as not related, possibly or probably related to SYN321
Measured: From IMP injection (day 1) until end of trial visit (day 56)
Clinically significant changes in ECG
Single 12-lead ECGs will be recorded in supine position after 10 minutes of rest using an ECG machine. The resting heart rate and PQ/PR, QRS, QT and QTcF intervals will be recorded. Any values outside of normal ranges will be judged as clinically significant or not clinically significant by the Investigator. Abnormal post-IMP administration findings assessed by the Investigator as clinically significant will be reported as Adverse Events.
Measured: From screening until end of trial visit (day 56)
Clinically significant changes in blood pressure
Systolic and diastolic blood pressure and pulse will be measured in supine positionafter 10 minutes of rest. Any vital signs outside of normal ranges will be judged as clinically significant or not clinically significant by the Investigator. Abnormal post-IMP administration findings assessed by the Investigator as clinically significant will be reported as Adverse Events.
Measured: From screening until end of trial visit (day 56)
Clinically significant changes in heart rate
Heart rate will be measured in supine position after 10 minutes of rest. Any vital signs outside of normal ranges will be judged as clinically significant or not clinically significant by the Investigator. Abnormal post-IMP administration findings assessed by the Investigator as clinically significant will be reported as Adverse Events.
Measured: From screening until end of trial visit (day 56)
Clinically significant changes in body temperature
Body temperature will be measured in supine position after 10 minutes of rest. Any vital signs outside of normal ranges will be judged as clinically significant or not clinically significant by the Investigator. Abnormal post-IMP administration findings assessed by the Investigator as clinically significant will be reported as Adverse Events.
Measured: From screening until end of trial visit (day 56)
Clinically significant changes in Clinical Laboratory Profile
Safety laboratory data, Clinical chemistry, haematology, and coagulation, will be measured. Any values outside of normal ranges will be judged as clinically significant or not clinically significant by the Investigator. Abnormal post-IMP administration findings assessed by the Investigator as clinically significant will be reported as Adverse Events.
Measured: From screening until end of trial visit (day 56)
Clinically significant changes in urine analysis
Urine analysis will be performed. Any values outside of normal ranges will be judged as clinically significant or not clinically significant by the Investigator. Abnormal post-IMP administration findings assessed by the Investigator as clinically significant will be reported as Adverse Events.
Measured: From screening until end of trial visit (day 56)
Clinically significant changes in Physical Examination
Assessment of different organ systems. Any abnormalities will be specified and documented as clinically significant or not clinically significant. Abnormal post-IMP administration findings assessed by the Investigator as clinically significant will be reported as AEs
Measured: From screening until end of trial visit (day 56)
Clinically significant changes of local tolerability reactions
The infusion site area will be visually inspected at baseline and follow up-visits after the IMP injection. The assessment will include the Investigator's evaluation of swelling, Redness and warmth. Abnormal post-IMP administration findings assessed by the Investigator as clinically significant will be reported as AEs.
Measured: From screening until end of trial visit (day 56)
Secondary outcomes (10)
Pharmacokinetic (PK) parameter in plasma - Cmax
Venous samples for the determination of plasma concentrations (Cmax) of diclofenac and diclofenac lactam (break down products from SYN321) will be collected.
Measured: From IMP injection (day 1) until end of trial visit (day 56)
Pharmacokinetic (PK) parameter in plasma - Cmax
Venous samples for the determination of plasma concentrations (Cmax) of linker and linker associated metabolites (break down products from SYN321) will be collected.
Measured: From IMP injection (day 1) until end of trial visit (day 56)
Pharmacokinetic (PK) parameter in urine - Cmax
Urine samples for the determination of plasma concentrations (Cmax) of diclofenac and diclofenac lactam (break down products from SYN321) will be collected.
Measured: From IMP injection (day 1) until end of trial visit (day 56)
Pharmacokinetic (PK) parameter in urine - Cmax
Urine samples for the determination of plasma concentrations (Cmax) of linker and linker associated metabolites (break down products from SYN321) will be collected.
Measured: From IMP injection (day 1) until end of trial visit (day 56)
Pharmacokinetic (PK) parameter in plasma - AUC
Venous samples for the determination of plasma concentrations (AUC) of diclofenac and diclofenac lactam (break down products from SYN321) will be collected.
Measured: From IMP injection (day 1) until end of trial visit (day 56)
Pharmacokinetic (PK) parameter in plasma - AUC
Venous samples for the determination of plasma concentrations (AUC) of linker and linker associated metabolites (break down products from SYN321) will be collected.
Measured: From IMP injection (day 1) until end of trial visit (day 56)
Pharacokinetic (PK) parameter in urine - AUC
Urine samples for the determination of plasma concentrations (AUC) of diclofenac and diclofenac lactam (break down products from SYN321) will be collected.
Measured: From IMP injection (day 1) until end of trial visit (day 56)
Self-registered pain in knee
Self-registered pain using the NRS (0-10). Score 0 indicates 'no pain' and 10 indicates 'pain as bad as you can imagine'.
Measured: From screening until end of trial visit (day 56)
Self-registered function
Self-registered function using KOOS (Knee Injury and Osteoarthritis Outcome Score). Change from baseline in average sum of KOOS scores, KOOS subscale scores. The patients will assign scores (0-4, where 0 corresponds to "none" and 4 corresponds to "extreme").
Measured: From IMP injection until end of trial visit (day 56)
Self-registered quality of life
Self-registered function using KOOS (Knee Injury and Osteoarthritis Outcome Score). Change from baseline in average sum of KOOS scores, KOOS subscale scores. The patients will assign scores (0-4, where 0 corresponds to "none" and 4 corresponds to "extreme").
Measured: From IMP injection until end of trial visit (day 56)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start19 Aug 2025
- Primary completion2 Feb 2026
- Study completion2 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of 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 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Synartro AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CTC Clinical Trial Consultants AB
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06989645
- Sponsor's protocol ID
- SYN321-01
- Other IDs
- 2024-517920-21-00
- Status last verified
- Mar 2026
- First submitted
- 16 May 2025
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Double-blinded, Randomized, Placebo-controlled Phase 1/2a Study to Assess Safety, Tolerability, Systemic Exposure, and Preliminary Efficacy of Single Intraarticular Injections of 3 Dose Levels of SYN321 and Placebo in Patients With Symptomatic Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06989645
- Acronym / sponsor ID
- SYN321-01
- Conditions
- Osteoarthritis of Knee
- Keywords
- knee osteoarthritis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Synartro ABIndustry (pharma, biotech, devices)
- Collaborators
- CTC Clinical Trial Consultants AB
- Study start
- 19 Aug 2025 (actual)
- Primary completion
- 2 Feb 2026 (actual)
- Study completion
- 2 Mar 2026 (actual)
- First posted
- 25 May 2025 (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 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).
Detailed description
Participants will receive a single intra-articular injection of SYN321 or placebo. 4 sequential cohorts are planned. The fourth cohort will repeat one of the previously 3 administered dose levels. The first 2 participants in each cohort will be dosed in a sentinel fashion. The participants will be followed for 56 days.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| SYN321, dose level 1 | Active comparator | Drug: SYN321Cohort 1: 6 participants recieves SYN321. |
| SYN321, dose level 2 | Active comparator | Drug: SYN321Cohort 2: 6 participants recieves SYN321. |
| SYN321, dose level 3 | Active comparator | Drug: SYN321Cohort 3: 6 participants recieves SYN321. |
| SYN321, dose level 1,2 or 3 | Active comparator | Drug: SYN321Cohort 4: 6 participants recieves SYN321. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo: 2 participants each from cohort 1, 2 and 3, and 6 participants from cohort 4 receive placebo. |
Who may qualify
- Ages
- 40 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (28 listed)
- 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.
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 |
|---|---|---|
| SYN321Intra-articular | Drug | SYN321, dose level 1, SYN321, dose level 1,2 or 3, SYN321, dose level 2, SYN321, dose level 3 |
| PlaceboAlso: NaCl 9 mg/mLIntra-articular | Drug | Placebo |
Primary outcome
Incidence and intensity of adverse events
Time frame: From IMP injection (day 1) until end of trial visit (day 56)
Frequency, intensity and seriousness of adverse events (AEs) will be assesed. The intensity grades is defined as mild, moderate or severe. AEs will be assessed as not related, possibly or probably related to SYN321
Clinically significant changes in ECG
Time frame: From screening until end of trial visit (day 56)
Single 12-lead ECGs will be recorded in supine position after 10 minutes of rest using an ECG machine. The resting heart rate and PQ/PR, QRS, QT and QTcF intervals will be recorded. Any values outside of normal ranges will be judged as clinically significant or not clinically significant by the Investigator. Abnormal post-IMP administration findings assessed by the Investigator as clinically significant will be reported as Adverse Events.
Clinically significant changes in blood pressure
Time frame: From screening until end of trial visit (day 56)
Systolic and diastolic blood pressure and pulse will be measured in supine positionafter 10 minutes of rest. Any vital signs outside of normal ranges will be judged as clinically significant or not clinically significant by the Investigator. Abnormal post-IMP administration findings assessed by the Investigator as clinically significant will be reported as Adverse Events.
Clinically significant changes in heart rate
Time frame: From screening until end of trial visit (day 56)
Heart rate will be measured in supine position after 10 minutes of rest. Any vital signs outside of normal ranges will be judged as clinically significant or not clinically significant by the Investigator. Abnormal post-IMP administration findings assessed by the Investigator as clinically significant will be reported as Adverse Events.
Clinically significant changes in body temperature
Time frame: From screening until end of trial visit (day 56)
Body temperature will be measured in supine position after 10 minutes of rest. Any vital signs outside of normal ranges will be judged as clinically significant or not clinically significant by the Investigator. Abnormal post-IMP administration findings assessed by the Investigator as clinically significant will be reported as Adverse Events.
Clinically significant changes in Clinical Laboratory Profile
Time frame: From screening until end of trial visit (day 56)
Safety laboratory data, Clinical chemistry, haematology, and coagulation, will be measured. Any values outside of normal ranges will be judged as clinically significant or not clinically significant by the Investigator. Abnormal post-IMP administration findings assessed by the Investigator as clinically significant will be reported as Adverse Events.
Clinically significant changes in urine analysis
Time frame: From screening until end of trial visit (day 56)
Urine analysis will be performed. Any values outside of normal ranges will be judged as clinically significant or not clinically significant by the Investigator. Abnormal post-IMP administration findings assessed by the Investigator as clinically significant will be reported as Adverse Events.
Clinically significant changes in Physical Examination
Time frame: From screening until end of trial visit (day 56)
Assessment of different organ systems. Any abnormalities will be specified and documented as clinically significant or not clinically significant. Abnormal post-IMP administration findings assessed by the Investigator as clinically significant will be reported as AEs
Clinically significant changes of local tolerability reactions
Time frame: From screening until end of trial visit (day 56)
The infusion site area will be visually inspected at baseline and follow up-visits after the IMP injection. The assessment will include the Investigator's evaluation of swelling, Redness and warmth. Abnormal post-IMP administration findings assessed by the Investigator as clinically significant will be reported as AEs.
10 secondary outcomes
Pharmacokinetic (PK) parameter in plasma - Cmax
Time frame: From IMP injection (day 1) until end of trial visit (day 56)
Pharmacokinetic (PK) parameter in plasma - Cmax
Time frame: From IMP injection (day 1) until end of trial visit (day 56)
Pharmacokinetic (PK) parameter in urine - Cmax
Time frame: From IMP injection (day 1) until end of trial visit (day 56)
Pharmacokinetic (PK) parameter in urine - Cmax
Time frame: From IMP injection (day 1) until end of trial visit (day 56)
Pharmacokinetic (PK) parameter in plasma - AUC
Time frame: From IMP injection (day 1) until end of trial visit (day 56)
Pharmacokinetic (PK) parameter in plasma - AUC
Time frame: From IMP injection (day 1) until end of trial visit (day 56)
Pharacokinetic (PK) parameter in urine - AUC
Time frame: From IMP injection (day 1) until end of trial visit (day 56)
Self-registered pain in knee
Time frame: From screening until end of trial visit (day 56)
Self-registered function
Time frame: From IMP injection until end of trial visit (day 56)
Self-registered quality of life
Time frame: From IMP injection until end of trial visit (day 56)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Osteoarthritis of Knee
RecruitingPhase 3
Phase 3 Pivotal Trial Comparing CARTISTEM® and Surgical Comparator for Knee Cartilage Lesions and Osteoarthritis
Knee Cartilage Defects
Recruiting
The Effect of Different Exercise Training Programs on Muscle Oxygenation in Individuals With Knee Osteoarthritis
Osteoarthritis of Knee
Not yet recruiting
Comparison of Telerehabilitation and Usual Rehabilitation After Knee or Hip Surgery
Orthopedic Surgery, Rehabilitation
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
Recruiting
Exploration of Appropriate BIS Range and Propofol Effect-site Concentration During Total Intravenous Anesthesia With Concomitant Adjuvants.
Knee Osteoarthritis, Replacement, Knee
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SYN321 in people with Osteoarthritis of Knee, run by Synartro AB at 1 site in Sweden.
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 16 inclusion and 28 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: finished, as of the sponsor's last update on 6 Mar 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 Sweden. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and intensity of adverse events (time frame: From IMP injection (day 1) until end of trial visit (day 56)). The study lists 9 primary outcomes in all. 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 6 Mar 2026.