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

Primary Purpose

Osteoarthritis of the Knee

Status

Completed

Phase

Phase 1

Locations

Taiwan

Study Type

Interventional

Intervention

TLC599

About this trial

This is an interventional treatment trial for Osteoarthritis of the Knee focused on measuring osteoarthritis of the knee, TLC599, Dexamethasone, DSP

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

MacKay Memorial Hospital
Taipei Medical University Hospital
Taipei Veterans General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

6 mg TLC599

12 mg TLC599

Arm Description

6 mg DSP with 50 μmol PL

12 mg DSP with 100 μmol PL

Outcomes

Primary Outcome Measures

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

Number of participants with at least one TEAE

Secondary Outcome Measures

Full Information

NCT ID

NCT02803307

First Posted

May 23, 2016

Last Updated

May 5, 2022

Sponsor

Taiwan Liposome Company

1. Study Identification

Unique Protocol Identification Number

NCT02803307

Brief Title

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

Official Title

A Randomized, Open-label, Parallel, Phase I/II Single-Dose Administration Trial of TLC599 in Subjects With Osteoarthritis of the Knee

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Completed

Study Start Date

June 2015 (Actual)

Primary Completion Date

November 2016 (Actual)

Study Completion Date

November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Taiwan Liposome Company

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis of the Knee

Keywords

osteoarthritis of the knee, TLC599, Dexamethasone, DSP

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

6 mg TLC599

Arm Type

Experimental

Arm Description

6 mg DSP with 50 μmol PL

Arm Title

12 mg TLC599

Arm Type

Experimental

Arm Description

12 mg DSP with 100 μmol PL

Intervention Type

Drug

Intervention Name(s)

TLC599

Intervention Description

Single dose via intra-articular injection

Primary Outcome Measure Information:

Title

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

Description

Number of participants with at least one TEAE

Time Frame

up to 12 weeks after dosing

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Carl Brown, PhD

Organizational Affiliation

Taiwan Liposome Company

Official's Role

Study Director

Facility Information:

Facility Name

MacKay Memorial Hospital

City

Taipei

ZIP/Postal Code

104

Country

Taiwan

Facility Name

Taipei Medical University Hospital

City

Taipei

ZIP/Postal Code

110

Country

Taiwan

Facility Name

Taipei Veterans General Hospital

City

Taipei

ZIP/Postal Code

112

Country

Taiwan

12. IPD Sharing Statement

Plan to Share IPD

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

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