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

NCT02803307 | Completed Phase 1 Results DMC

• 1 other identifier: TLC599A1001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

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.

Conditions

Osteoarthritis of the Knee

Keywords

osteoarthritis of the knee; TLC599; Dexamethasone; DSP

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

  Number of participants with at least one TEAE

  up to 12 weeks after dosing

Study Arms (2)

6 mg TLC599

EXPERIMENTAL

6 mg DSP with 50 μmol PL

Drug: TLC599

12 mg TLC599

EXPERIMENTAL

12 mg DSP with 100 μmol PL

Drug: TLC599

Interventions

TLC599 DRUG

Single dose via intra-articular injection

12 mg TLC599; 6 mg TLC599

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects, at least 20 years of age
• Documented diagnosis of OA of the knee for at least 6 months
• At least a grade 2 severity based on the Kellgren and Lawrence Grading Scale
• VAS score of ≥ 4 at baseline

You may not qualify if:

• Subjects who received systemic corticosteroids for the last 30 days prior to baseline
• Subjects who received non-steroidal anti-inflammatory drug (NSAID), analgesics, or rehabilitations therapy within 7 days prior to baseline
• History of rheumatoid arthritis or other autoimmune disease
• Clinical signs and symptoms of acute infection or infection related inflammation in the other knee before dosing
• History of infective arthritis, suspected or concurrent infection, or suspected or confirmed crystal diseases (gout or pseudogout) of the study knee
• Concurrent systemic active or uncontrolled infectious disease
• 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)
• History of acquired or congenital immunodeficiency diseases
• Platelet count \< 80,000/μl, or blood coagulation disorders, including subjects with hemophilia, decompensated liver cirrhosis or uremia
• Stroke or myocardial infarction within 3 months prior to the screening visit
• 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
• 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
• Any skin lesion/breakdown at the anticipated injection site or any condition that impairs penetration of the study knee joint space
• 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

Sponsors & Collaborators

• Taiwan Liposome Company: lead

Study Sites (3)

MacKay Memorial Hospital

Taipei, 104, Taiwan

Location

Taipei Medical University Hospital

Taipei, 110, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 112, Taiwan

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Dr. Carl Brown
• Organization: Taiwan Liposome Company

carlb@tlcbio.com

886-2-2655-7377

Study Officials

• Carl Brown, PhD

  Taiwan Liposome Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2016
• First Posted: June 16, 2016
• Study Start: June 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: May 6, 2022
• Results First Posted: May 6, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (3)