IP 0299-0104 Part B

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

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 1 month 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 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.

 

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.