A Phase 2, Open Label, PK Study of TLC599 in Subject With Osteoarthritis of the Knee

• Status: Recruiting
• Trial end date: 2022-02-28
• Target enrollment: 0
• Participant gender: All

Summary

This study is a Phase 2, open-label, 1-period, parallel study with 9 cohorts of subjects with OA of the knee enrolled to receive single-dose of TLC599 or DSP via IA injection.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Taiwan Liposome Company
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

Criteria

Inclusion Criteria:

1. Male or female non or moderate smokers, 45 years or older, with BMI ≤ 40.0 kg/m2.

2. Has symptoms associated with OA of the knee for at least 6 months prior to Screening and confirmation of mild to moderate OA.

3. The study knee has OA with grade 1-3 in severity based on the Kellgren-Lawrence grades.

4. Females of childbearing potential to use acceptable contraceptive methods until 25 weeks after study drug administration.

5. Male subjects must to use acceptable contraceptive methods from dosing until 25 weeks after study drug administration.

6. Willing and able to comply with study procedures and provide written informed consent.

Exclusion Criteria:

1. Clinically significant abnormality at physical examination, laboratory test results or positive test for hepatitis B, hepatitis C, or HIV

2. Positive urine drug screen

3. History of allergic reactions to TLC599, its components or other related drugs

4. Clinically significant and unstable illness

5. History of clinically significant autoimmune disease

6. Evidence of intra articular bleeding of the study knee

7. History of infective arthritis or suspected / concurrent infection in the study knee; clinical symptoms and signs of acute infection or infection-related inflammation in the non-study knee

8. Skin lesion/breakdown at the anticipated injection site or any condition that would impair penetration of the study knee joint space.

9. Total white blood cell count <4000/ μL or >13000/ μL.

10. History of acquired or congenital immunodeficiency diseases.

11. History of treated malignancy which is disease free for ≤ 5 years

12. Stroke or myocardial infarction within 3 months

13. Subjects with a condition or in a situation which will interfere with the subject's ability to comply or cooperate with the dosing and visit schedules and the protocol evaluations or may not be suitable for this study

14. Clinically significant ECG abnormalities or vital sign abnormalities

15. History of significant alcohol abuse within one year or regular use of alcohol within six months

16. History of significant drug abuse within one year or use of soft drugs within 3 months or hard drugs within 1 year

17. Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days, administration of a biological product in the context of a clinical research study within 90 days

18. Any use of medication

1. drugs known to induce or inhibit hepatic CYP 3A4 metabolism within 30 days

2. prescription medication within 14 days

3. over-the-counter products and natural health products within 7 days

4. prescription medication known to affect platelet function within 14 days

5. a depot injection or an implant of any drug within 3 months

6. use of IA corticosteroid, hyaluronic acid, or other IA injection in the study knee within 6 months

7. any IA injection drug that could impact endogenous steroid levels within 6 months

8. systemic corticosteroids within 30 days

9. use of any chemotherapeutic or systemic immunosuppressant agents for inflammatory diseases within 6 months

19. Donation of plasma within 7 days. Donation or loss of blood of 50mL to 499 mL of blood within 30 days, or more than 499 mL within 56 days

20. Female subjects who are pregnant, breast-feeding, or plan to become pregnant/breast-feeding

21. History of latent or active tuberculosis or exposure to endemic areas within 8 weeks

22. Positive TB test indicating possible tuberculosis infection

23. Immunization with a live attenuated vaccine 1 month or planned during the course of the study

24. History of clinically significant opportunistic infection

25. Serious local infection or systemic infection within the 3 months

26. Presence of a symptomatic viral or bacterial infection within 2 weeks

27. Subjects with current diagnosis of severe OA with grade 4 classification in the non-study knee based on the Kellgren-Lawrence grades

28. Subject who had a surgery within 4 weeks or expected to have knee replacement surgery scheduled during his/her study duration

29. Subjects with known history of adrenal insufficiency or with potential risk of adrenal insufficiency

30. History of allergic reactions to cosyntropin

31. Patient with any lower limb amputation

32. Inadequate synovial fluid collection of the study knee joint