Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Biosplice Therapeutics, Inc.
Age
18–55
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
1. Males and females between 18 and 55 years of age, inclusive, in general good health
2. Body mass index (BMI) ≥ 18.5 and ≤ 32.0 kg/m2 at Screening
3. Negative drug test for amphetamine, cocaine, methadone, opiates, phencyclidine (PCP), barbiturates, benzodiazepines, tricyclic antidepressants, and marijuana
You may not be if
1. Pregnant women, breastfeeding women, and women who are not post-menopausal (defined as 12 months with no menses without an alternative medical cause) or permanently surgically sterile (includes hysterectomy, bilateral salpingectomy, and bilateral oophorectomy) who have a positive or indeterminate pregnancy test result at the Screening Visit or Day -1
2. Women who are not post-menopausal or permanently surgically sterile who are sexually active, and who are not willing to use birth control during the study period
3. Men who are sexually active and of reproductive potential, who have partners who are capable of becoming pregnant, and who are not willing to use birth control during the study period
4. Any chronic medical condition that requires medication
5. Any history of IA injection, surgery (e.g., arthroscopy), infection, major orthopedic injury, or inflammatory rheumatic diseases (e.g., rheumatoid arthritis, gout, pseudogout) of either knee
6. Any contraindications for an IA injection in the right knee in the opinion of the Investigator
7. Previous treatment with lorecivivint (LOR)
8. Treatment with any glucocorticoids (oral, intravenous, intramuscular, IA, topical, or inhaled) within 12 weeks before Day 1
9. Consumption of grapefruit, grapefruit juice, Seville oranges, or vegetables from the mustard green family (e.g., kale, broccoli, watercress, collard greens, kohlrabi, brussels sprouts) within 10 days before Day 1
10. Known hypersensitivity to triamcinolone acetonide (TA)
11. Significant blood loss (\> 500 mL) or donation of blood within 30 days of screening
12. Regular use of nicotine-containing products, including, but not limited to, cigarettes, e-cigarettes, or nicotine gum or patches
13. Any condition, that, in the opinion of the Investigator, constitutes a risk or contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation
14. Estimated glomerular filtration rate (eGFR) of \< 60 mL/min/1.73 m2, calculated using the Modification of Diet in Renal Disease (MDRD) equation at the Screening Visit
