CompletedPhase 2

A Phase 2, Open Label, Pharmacokinetic (PK) Study of TLC599 in Subjects With Osteoarthritis of the Knee

United States, Taiwan102 participantsStarted 2019-01-21

Plain-language summary

This study is a multi-center, Phase 2, open-label, 1-period, parallel study with 9 cohorts of subjects with osteoarthritis (OA) of the knee enrolled to receive single-dose of TLC599 or Dexamethasone sodium phosphate (DSP) via IA injection and 1 cohort of healthy subjects to receive single-dose of DSP via intravenous (IV) injection.

Who can participate

Age range

18 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.

Study Criteria for Patients with OA of the Knee (Cohort G1-G9) Inclusion Criteria: * Age 45 or older, non or moderate smokers, body mass index (BMI) ≤ 40.0 kg/m2. * Knee OA symptoms with confirmed mild to moderate OA. * Study knee OA severity grade 1-3 (Kellgren-Lawrence). * Agree to use contraception Exclusion Criteria: * Clinically significant (CS) abnormalities (physical, lab, hepatitis B/C, HIV, electrocardiogram \[ECG\], vital sign or unstable illness). * Positive urine drug screen, tuberculosis (TB) test; significant alcohol/drug abuse * Allergic reactions to TLC599, its components, related drugs or cosyntropin. * History of autoimmune disease, immunodeficiency diseases, treated malignancy, CS opportunistic infection, tuberculosis, infective arthritis or concurrent knee infection * Intra-articular bleeding in study knee. * Skin issues at injection site or hindrance to knee joint penetration. * Blood coagulation disorders. * Stroke or myocardial infarction * Poorly controlled hypertension or vital sign abnormalities. * Interfering conditions with dosing, visits, or compliance or refusal of synovial fluid collection. * Medication: Strong/moderate Cytochrome P450 (CYP) 3A/3A4 inhibitors/inducers, prescription meds, over-the-counter (OTC)/natural health products, meds affecting platelet function, depot injection/implant, IA corticosteroid, hyaluronic acid, or other injection in study knee, impact on endogenous steroid levels, systemic corticosteroids, live attenuated va…

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

Area under the Curve [AUC]

Timeframe: Baseline till 24 weeks post investigational product (IP) administration

Cmax: maximum concentration

Timeframe: Baseline till 24 weeks post IP administration

Tmax: time to peak concentration

Timeframe: Baseline till 24 weeks post IP administration

Trial details

NCT IDNCT03754049

SponsorTaiwan Liposome Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-11-07

View on ClinicalTrials.gov More Osteoarthritis of the Knee trials