None listed
Conditions
Brief summary
The purpose of phase 1 study is to evaluate the Pharmacokinetics, Safety, Tolerability of APC201 in Healthy Adults.
Interventions
Apply APC201 topically twice daily on both knees for 1 week, a participant’s adherence to the assigned treatment plan will be assessed by reviewing entries on his/her diary card at each return visit.
The intended dose of APC201 per administration is 3 actuations (0.75 mL x 3), equivalent to 94 mg of diclofenac sodium per knee for each administration.
Sponsors
Andros Pharmaceuticals Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male or female adult, 18 to 85 years of age, inclusive at the time of screening. 2. If female of childbearing potential, subject must be not pregnant as assessed by a pregnancy test at screening and agree to use an acceptable method of contraception (progestogen-only hormonal contraception, where inhibition of ovulation is not the primary mode of action, male or female condom with or without spermicide, cap, diaphragm or sponge with spermicide) from enrolment up to 30 days after the study end. Female subject being postmenopausal for at least 1 year or surgically sterile is considered to be of no childbearing potential. 3. The subject has a body mass index (BMI) is greater than or equal to 18.5 and less than 40. 4. The health status is assessed by the investigator as “normal healthy” based on required screening assessments. 5. The subject provided written informed consent. 6. Subject agrees to maintain the usual activity level throughout the course of the study. 7. Subject must agree to not showering, swimming or wetting the treated knee(s) for 2 hours post application. 8. Subject must agree to avoid exposing the treated knee(s) to natural or artificial sunlight.
Exclusion criteria
1. Known or suspected hypersensitivity to NSAIDs (non-steroidal anti-inflammatory drugs), any of the components in either of the investigational products (IPs), or any physical impediment to apply IP on the knees. 2. Known presence of gastrointestinal ulcer or any gastrointestinal bleeding within 6 months prior to Day 1. 3. Surgery or arthroscopy of knee(s) within one year prior to Day 1. 5. Skin disorder that affects palms of the hands or the application site of the knee(s). 6. History of diabetes. 7. Donation or significant loss of blood (480 mL or more) within 60 days prior to Day 1. 8. Administration of an investigational drug within 30 days prior to Day 1. 10. Subject treated with systemic or local NSAIDs within 30 days prior to Day 1. 11. Smoked or used nicotine-containing products within 6 months prior to Day 1. 12. Has used cannabis or any CBD or THC-containing product within 30 days of the screening visit and during the study. 13. Subject plans to use any OTC cosmetic tanning lotions to the target knee while on study. 14. Abnormal hepatic and renal functions; hematologic changes at screening: The value of Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) is greater than or equal to 2.5 times upper limit of normal; The value of Total bilirubin is greater than or equal to 1.5 times upper limit of normal; The value of Serum creatinine is greater than or equal to 1.5 times upper limit of normal; The value of Hemoglobin is less than or equal to lower limit of normal.
Outcome results
None listed