Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years and Over|
Cohort G1-G9 Study Criteria.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Taiwan Liposome Company|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Terry Tai, MD|
|Principal Investigator Affiliation||Taiwan Liposome Company|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Countries||Taiwan, United States|
The disease, disorder, syndrome, illness, or injury that is being studied.
|OSTEOARTHRITIS OF THE KNEE|
This Phase 2, open-label, 1 period, parallel study will enroll. 1. approximately 90 subjects to receive a single dose of TLC599 or DSP via IA injection, followed by a PK evaluation period up to 24 weeks and an additional follow-up period of 1 to 5 weeks. Additional subjects may be recruited as needed to achieve at least 10 subjects completing the 1-week blood collection period for each treatment. 2. approximately 12 healthy subjects to recieve a single dose of DSP via IV injection, followed by a PK evaluation period up to 1 week and an additional follow-up period of 1 week. Additional subjects may be recruited as needed to achieve at least 12 subjects completing the 48-hour blood collection period for IV DSP.
Experimental: TLC599 12 mg
12 mg DSP with 100 μmol phospholipid via IA injection;
Experimental: TLC599 6 mg
6 mg DSP with 50 μmol phospholipid via IA injection.
Active Comparator: DSP 4mg
Dexamethasone Sodium Phosphate (DSP): 4 mg/mL, 1 mL via IA injection.
Active Comparator: DSP 10mg
Dexamethasone Sodium Phosphate (DSP): 4 mg/mL, 2.5 mL via IV injection.
Drug: - TLC599
TLC599 is manufactured with the proprietary lipid formulation in lyophilized form (BioSeizer) for the reconstitution with the aqueous DSP (active ingredient).
Drug: - DSP
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.
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.