Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-25 @ 4:12 AM
NCT ID:
NCT05948020
Eligibility Criteria:
Inclusion Criteria:
* Blood phe ≥ 600μmol/L at newborn screening;
* Blood phe ≥ 600μmol/L at least 3 times in the last 1 year before screening, and the blood Phe ≥ 600μmol/L in the last 1 time;
* Screening laboratory evaluations (e.g., chemistry panel, complete blood count, urinalysis, creatinine clearance, CRP) within normal limits or judged to be not clinically significant by the investigator;
* Stable diet for at least 60 days prior to screening;
* Able to produce at least 2 bowel movements per week on average without using any form of laxatives;
* Adolescents and children's guardians can voluntarily complete the whole process of informed consent, including stool, urine and blood collection, adherence to diet control, hospital monitoring, follow-up and oral trial drug compliance, and sign informed consent.
Exclusion Criteria:
* The standard percentile values of height and weight of Chinese children aged 0 to 18 years were evaluated with weight less than P3 or weight greater than P97；
* History of active or chronic passage of 3 or more loose stools per day；
* Have any medical conditions or medications that may affect the absorption of medications or nutrients；
* History of or current immunodeficiency disorder including autoimmune disorders；
* Subjects with obvious influenza-like symptoms caused by COVID-19 or other viral infections during screening；
* Hepatitis B surface antigen and/or hepatitis C antibodies and/or treponema pallidum antibodies positive；
* Subjects who are dependent on drugs and alcohol；
* Received gene therapy related to PKU；
* Intolerant or allergic to Escherichia coli Nissle 1917 (EcN)；
* Active gastrointestinal bleeding or a proven history of gastrointestinal bleeding within 60 days prior to screening；
* Antibiotics within 28 days before the planned first dose of investigational product (IP), or anticipated during the study period；
* Take probiotic supplements within 28 days before the planned first dose of IP, or anticipated during the study period；
* A history of fever, confirmed bacteremia, or other active infection within 30 days prior to the planned first dose of IP；
* Drugs that use of the digestive system has been used within 30 days prior to the planned first dose of IP;
* Drugs that may affect gastrointestinal function has been used within 30 days prior to the planned first dose of IP;
* Major survery performed within 90 days before the anticipated first dose of IP or planned surgery or hospitalization during the study period；
* Take sapropterin (KUVAN®) within 1 week before the planned first dose of IP；
* Use pegylated recombinant phenylalanine ammonia lyase (PALYNZIQ™) within 30 days before the planned first dose of IP；
* History of severe immune adverse reactions to PALYZIQ；
* Participated in an interventional clinical trial and used the investigational drug within 60 days or 5 half-lives before the planned first dose of IP；
* Subjects who may not be able to complete the study for other reasons.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
17 Years
Study:
NCT05948020
Study Brief:
Protocol Section:
NCT05948020