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

Completed · Phase 2

Conditions studied: Osteoarthritis of the Knee

In brief

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.

Key facts

Study ID

NCT03754049

Run by

Taiwan Liposome Company

People needed

102

Starts

2019-01-21

Expected to finish

2023-11-07

Last updated by the study team

2024-10-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 vaccine, chemotherapeutic/immunosuppressant use for inflammatory diseases.
• Plasma donation or significant blood loss.
• Pregnancy, breastfeeding, or planning to be pregnant/breastfeed
• Serious local/systemic infection or symptomatic viral/bacterial infection
• Severe OA (grade 4) in non-study knee (Kellgren-Lawrence).
• Recent surgery, scheduled knee replacement or lower limb amputation.
• Known/adrenal insufficiency risk.
• Recent participation in other study research
• Study Criteria for Healthy Subjects (Cohort G10)
• Inclusion Criteria:
• Age 18-45, non-smokers, BMI 18.5-25 kg/m2, body weight ≥ 50.0 kg (males) or ≥ 45.0 kg (females).
• Healthy with no CS illness/surgery within 4 weeks or CS medical history.
• Agree to use contraception
• No new tattoos/body piercings at the injection site until the study ends.
• Exclusion Criteria:

Where it is running

• Arizona Research Center — Phoenix, Arizona, United States
• Panax Clinical Research — Miami, Florida, United States
• South Coast Research Center — Miami, Florida, United States
• Syneos Health — Miami, Florida, United States
• Clinical Trials of South Carolina — Charleston, South Carolina, United States
• Futuro Clinical Trials, LLC. — McAllen, Texas, United States
• JBR Clinical Research — Salt Lake City, Utah, United States
• China Medical University Hospital — Taichung, Taiwan
• Tri-Service General Hospital — Taipei, Taiwan
• Taipei Municipal Wanfang Hospital — Taipei, Taiwan

Full record on ClinicalTrials.gov

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