Working to Find a New PKU Treatment

All Study Participants Receive at No Cost:

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Close care and monitoring throughout the study

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Investigational drug

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All study-related visits

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Compensation for participation, including travel and study-related activities

The Investigational Drug: SYNB1618

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SYNB1618, a modified probiotic designed to break down phenylalanine in the diet

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Received as a packet of dry powder that participants will mix with water and drink

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Will be taken up to three times each day in four increasing doses for a total of 15 days

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Has been shown to be safe in two different clinical studies

Study Schedule (Up to 98 days in Duration):

You will learn more about the study. If you decide to take part, you will need to sign the Informed Consent Form.

Your study doctor will examine you (in the clinic or your home or other preferred location by a home healthcare professional), perform tests, and ask questions to find out if you are eligible to take part in the study. You will also speak with a research dietitian.

The screening period includes a six day diet run-in which you will initiate the study diet designed by you and your study dietitian. The diet run-in starts one week before receiving the study drug for the first time and continues through the Follow-Up Visit.

The screening period also includes a baseline visit the day before your first dose of study drug. You will have tests completed (in the clinic or your home or other preferred location by a home healthcare professional) and study entry criteria reviewed. Any changes in your health will be recorded.

You will receive the study drug up to three times a day with food. Every day or every few days you will receive a higher dose of the study drug than the previous day(s). There will be a total of four dose increases over a total of 15 days.

You will have tests done by a study staff member in the clinic or your home or other preferred location by a home healthcare professional on Day 1, Day 7, Day 14, and Day 15. In addition, you will be contacted by telephone to talk with a study team member approximately three times per week throughout the study through the Follow-Up Visit.

You will have tests done by a study staff member in the clinic or your home or other preferred location by a home healthcare professional. You will be asked some questions about your health. You will be asked to report any changes in your health to your study doctor through the End of Study (approximately two weeks following the Follow-Up Visit).

You will be contacted by telephone to talk about how you are feeling and discuss any changes in your health or medications.