Single-Dose Administration Trial of TLC599 in Osteoarthritis of the Knee

NCT ID: NCT02803307

Last Updated: 2022-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2016-11-30

Brief Summary

This trial is a multi-site, randomized, open-label, parallel, and single-dose administration study to investigate the safety and efficacy of TLC599 in subjects with osteoarthritis of the knee.

Detailed Description

Protocol No: TLC599A1001

Name of Finished Product: TLC599

Title of Study:

A Randomized, Open-label, Parallel, Phase I/II Single-Dose Administration trial of TLC599 in Subjects with Osteoarthritis (OA) of the Knee

Methodology This trial is a multi-site, randomized, open-label, parallel, and single-dose administration study to investigate the safety and efficacy of TLC599 in subjects with osteoarthritis of the knee.

Study duration:

The trial will last 14 weeks including a 14-day screening period and a 12-week follow-up period.

Conditions

Osteoarthritis of the Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

6 mg TLC599

6 mg DSP with 50 μmol PL

Group Type: EXPERIMENTAL

TLC599

Intervention Type: DRUG

Single dose via intra-articular injection

12 mg TLC599

12 mg DSP with 100 μmol PL

Group Type: EXPERIMENTAL

TLC599

Intervention Type: DRUG

Single dose via intra-articular injection

Interventions

TLC599

Single dose via intra-articular injection

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Male or female subjects, at least 20 years of age

2. Documented diagnosis of OA of the knee for at least 6 months

3. At least a grade 2 severity based on the Kellgren and Lawrence Grading Scale

4. VAS score of ≥ 4 at baseline

Exclusion Criteria

1. Subjects who received systemic corticosteroids for the last 30 days prior to baseline

2. Subjects who received non-steroidal anti-inflammatory drug (NSAID), analgesics, or rehabilitations therapy within 7 days prior to baseline

3. History of rheumatoid arthritis or other autoimmune disease

4. Clinical signs and symptoms of acute infection or infection related inflammation in the other knee before dosing

5. History of infective arthritis, suspected or concurrent infection, or suspected or confirmed crystal diseases (gout or pseudogout) of the study knee

6. Concurrent systemic active or uncontrolled infectious disease

7. A history of treated malignancy which is disease free for ≤ 5 years. (The malignancy does not include non-basal-cell carcinoma of skin or carcinoma-insitu of the uterine cervix)

8. History of acquired or congenital immunodeficiency diseases

9. Platelet count < 80,000/μl, or blood coagulation disorders, including subjects with hemophilia, decompensated liver cirrhosis or uremia

10. Stroke or myocardial infarction within 3 months prior to the screening visit

11. Use of intra-articular corticosteroid, hyaluronic acid, or other intra-articular injection in the study knee joint within 3 months prior to the screening visit

12. Unstable study knee joint, including anterior cruciate ligament, any surgery to the study knee within the 12 months prior to the screening visit, and any prior arthroscopic or open surgery of the study knee or any planned/anticipated surgery during the study period

13. Any skin lesion/breakdown at the anticipated injection site or any condition that impairs penetration of the study knee joint space

14. Female subjects who are pregnant, nursing, planning pregnancy, or who are of childbearing potential and not using reliable means of contraception 15.Known allergy or hypersensitivity to the study drug or its components

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taiwan Liposome Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carl Brown, PhD

Role: STUDY_DIRECTOR

Taiwan Liposome Company

Locations

MacKay Memorial Hospital

Taipei, , Taiwan

Taipei Medical University Hospital

Taipei, , Taiwan

Taipei Veterans General Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

TLC599A1001

Identifier Type: -

Identifier Source: org_study_id