A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of AG-181 in Adults and Adolescents with Phenylketonuria

The primary objective of this study is to evaluate the efficacy of AG-181 in individuals aged 18 to 69 years diagnosed with phenylketonuria. This investigation focuses on the therapeutic potential of the intervention to manage the metabolic disturbances associated with this condition.

The study population consists of 3 patients diagnosed with phenylketonuria. The cohort includes both male and female participants categorized as vulnerable. The age range of the subjects corresponds to the 3 to 4 year age group.

This Phase 3 clinical trial is designed to evaluate the efficacy and safety of AG-181 in subjects aged 18 to 69 years diagnosed with phenylketonuria. The study involves a sequence of clinical assessments beginning with a screening visit to determine eligibility. Subsequent follow-up visits are scheduled to monitor physiological responses and clinical outcomes, concluding with an end-of-study visit. The total duration of participant involvement is determined by the study protocol, though early termination may occur based on predefined clinical criteria or safety requirements. The overall study period is estimated to span from April 2026 to March 2028.

Efficacy assessment in this Phase 3 clinical trial for phenylketonuria is not specified in the provided documentation.