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Status:

COMPLETED

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

Lead Sponsor:

Taiwan Liposome Company

Conditions:

Osteoarthritis of the Knee

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief 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 s...

Detailed Description

This Phase 2, open-label, 1 period, parallel study will enroll 1. approximately 90 subjects to receive a single dose of TLC599 or DSP via intra-articular (IA) injection, followed by a PK evaluation p...

Eligibility Criteria

Inclusion

  • Study Criteria for Patients with OA of the Knee (Cohort G1-G9)
  • 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

  • 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.

Key Trial Info

Start Date :

January 21 2019

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

November 7 2023

Estimated Enrollment :

102 Patients enrolled

Trial Details

Trial ID

NCT03754049

Start Date

January 21 2019

End Date

November 7 2023

Last Update

October 23 2024

Active Locations (10)

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Page 1 of 3 (10 locations)

1

Arizona Research Center

Phoenix, Arizona, United States, 85053

2

Panax Clinical Research

Miami, Florida, United States, 33014

3

South Coast Research Center

Miami, Florida, United States, 33136

4

Syneos Health

Miami, Florida, United States, 33136