A Phase 2, Open Label, Pharmacokinetic (PK) Study of TLC599 in Subjects With Osteoarthritis of th… (NCT03754049) | Clinical Trial Compass
CompletedPhase 2
A Phase 2, Open Label, Pharmacokinetic (PK) Study of TLC599 in Subjects With Osteoarthritis of the Knee
United States102 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 range18 Years
SexALL
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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…
What they're measuring
1
Area under the Curve [AUC]
Timeframe: Baseline till 24 weeks post investigational product (IP) administration
2
Cmax: maximum concentration
Timeframe: Baseline till 24 weeks post IP administration
3
Tmax: time to peak concentration
Timeframe: Baseline till 24 weeks post IP administration