IP 0299-0104 Part A

Stipend and Dates

Up to $11,600.

All dates & times are tentative and may change. You cannot pick which cohort you go into.	Cohort A
Day -1 Admit	Apr 17, 2023
Day 19 Discharge	May 06, 2023

 

Click here to make an appointment for IP 0299-0104 Part A

Or call 210-225-5437 for more information

 

Study Criteria

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

 

Study Information

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 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:

Male participants:

• 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

Female participants:

            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.

 

Study Reminders

• 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.