Stipend and Dates
Up to $10,300.
|All dates & times are tentative and may change.||Cohort B|
|Day -1 Admit||Apr 24, 2023|
|Day 17 Discharge||May 11, 2023|
Click here to make an appointment for IP 0299-0104 Part B
Or call 210-225-5437 for more information
Healthy Males & Females – Non-Smoking
BMI: 18 to 30 kg/m2 Weight: at least 110 pounds
GFR: greater than 90 mL/min
Indication: The investigational drug 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
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 1 month 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 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 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.
- 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.
- IP 0299-0104 Part B
- Healthy Adults
- If you disqualified for Part A, you cannot screen for Part B.
- Male or Female
- Payment amount
- Up to $10,300
- 18 - 55