Healthy Volunteers for Investigational Drug for the Treatment of FOP
This study is for the investigational drug that is being developed as a possible treatment of FOP: disabling disease characterized by the formation of extra skeletal bone in muscle and soft tissue. Often associated with swelling in muscles, tendons, and ligaments. Route of Administration: Oral
- Admission Date: April 17, 2023
- Discharge Date: May 6, 2023
- 4 hours fasting is required for lab work (only water is allowed)
- If taking medications, bring them to your screening appointment (including prescription, over the counter, herbal supplements and vitamins)
- Bring a valid, non-expired photo ID with you when you attend your screening visit. We accept a valid government issued identification card such as a driver’s license, state issued ID card or passport. You will be required to show this same photo ID at all study visits
- Arrive 30 minutes before your appointment to complete paper work.
Up to $11,600
- Healthy Males & Females – Non-Smoking
- Age: 18-55
- BMI: 18 to 30 kg/m2 Weight: at least 110 pounds
- GFR: greater than 90 mL/min
Washout from previous study: Receipt of an investigational drug within 30 days or 6 half-lives before dosing.
Males or Females of childbearing potential are eligible to participate if they agree to the following during the intervention period and for at least 90 days for males and at least 1 month for females after the last study intervention dose, provided that contraceptive methods used by male or female participant are consistent with local regulations:
- Refrain from donating sperm
- Must agree to use a male condom with a female of childbearing potential who also uses an additional highly effective contraceptive method with a failure rate of <1% per year
Females of childbearing potential must have a negative blood pregnancy test prior to administration of study intervention. They must agree to remain abstinent from heterosexual sex during the study period and for at least 1 month after the last administration of treatment. If sexually active, must agree to use two effective methods of birth control, one of which must be highly effective with a failure rate of <1% per year during the study course and for at least 1 month after the last study intervention. Oral hormonal contraceptives are not considered highly effective for this study.
Sexually active females of childbearing potential in a heterosexual relationship must already be using two effective methods of birth control (one of which must be highly effective) 1 month before the first dose of the study intervention.