NCT03754049

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 sodium phosphate (DSP) via IA injection and 1 cohort of healthy subjects to receive single-dose of DSP via intravenous (IV) injection.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2019

Longer than P75 for phase_2

Geographic Reach
2 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 27, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

January 21, 2019

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 7, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 7, 2023

Completed
Last Updated

October 23, 2024

Status Verified

October 1, 2024

Enrollment Period

4.8 years

First QC Date

November 16, 2018

Last Update Submit

October 22, 2024

Conditions

Osteoarthritis of the Knee

Outcome Measures

Primary Outcomes (3)

  • Area under the Curve [AUC]

    Area under the concentration-time curve

    Baseline till 24 weeks post investigational product (IP) administration

  • Cmax: maximum concentration

    Maximum concentration

    Baseline till 24 weeks post IP administration

  • Tmax: time to peak concentration

    Time to peak concentration

    Baseline till 24 weeks post IP administration

Secondary Outcomes (2)

  • Number of adverse events (AEs), including serious adverse event (SAE) and treatment-emergent AE

    Screening till 25 weeks post IP administration

  • Cortisol concentration

    baseline till 24 weeks post IP administration

Study Arms (4)

TLC599 12 mg

EXPERIMENTAL

12 mg TLC590 (proprietary lipid formulation that consists of 12 mg DSP \[active ingredient\] with 100 μmol phospholipid) via IA injection in patients with OA of the knee. This 12 mg TLC599 treatment arm consists of six (6) cohorts (G1 to G6), each with different follow-up periods or visit schedules. However, the results will be pooled into a single treatment arm to allow for meaningful analysis across the various synovial fluid (SF) time points, as each subject only has one opportunity to collect an SF sample.

Drug: TLC599

TLC599 6 mg

EXPERIMENTAL

6 mg TLC590 (proprietary lipid formulation that consists of 6 mg DSP \[active ingredient\] with 50 μmol phospholipid) via IA injection in patients with OA of the knee. This 6 mg TLC599 treatment arm consists of two (2) cohorts (G7 and G8), each with different follow-up periods or visit schedules. However, the results will be pooled into a single treatment arm to allow for meaningful analysis across the various synovial fluid (SF) time points, as each subject only has one opportunity to collect an SF sample.

Drug: TLC599

DSP 4 mg

ACTIVE COMPARATOR

Dexamethasone Sodium Phosphate (DSP) at a concentration of 4 mg/mL, 1 mL for a total of 4 mg DSP via IA injection in patients with OA of the knee (G9).

Drug: DSP

DSP 10 mg

ACTIVE COMPARATOR

Dexamethasone Sodium Phosphate (DSP) at a concentration of 4 mg/mL, 2.5 mL for the total of 10 mg DSP via IV injection in healthy subjects (G10).

Drug: DSP

Interventions

TLC599DRUG

TLC599 is manufactured with the proprietary lipid formulation in lyophilized form (BioSeizer) for the reconstitution with the aqueous DSP (active ingredient).

Also known as: TLC599 Injection
TLC599 12 mgTLC599 6 mg
DSPDRUG

Dexamethasone sodium phosphate (DSP) is a glucocorticoid widely used in the treatment of joint pain such as gout, osteoarthritis and rheumatoid arthritis via IA injection.

Also known as: Dexamethasone Sodium Phosphate
DSP 10 mgDSP 4 mg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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).
  • +22 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Arizona Research Center

Phoenix, Arizona, 85053, United States

Location

Panax Clinical Research

Miami, Florida, 33014, United States

Location

South Coast Research Center

Miami, Florida, 33136, United States

Location

Syneos Health

Miami, Florida, 33136, United States

Location

Clinical Trials of South Carolina

Charleston, South Carolina, 29406, United States

Location

Futuro Clinical Trials, LLC.

McAllen, Texas, 78501, United States

Location

JBR Clinical Research

Salt Lake City, Utah, 84107, United States

Location

China Medical University Hospital

Taichung, 404, Taiwan

Location

Tri-Service General Hospital

Taipei, 114, Taiwan

Location

Taipei Municipal Wanfang Hospital

Taipei, 116, Taiwan

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

dexamethasone 21-phosphate

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Terry Tai, MD

    Taiwan Liposome Company

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2018

First Posted

November 27, 2018

Study Start

January 21, 2019

Primary Completion

November 7, 2023

Study Completion

November 7, 2023

Last Updated

October 23, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

US(7)TW(3)