Safety and Tolerability of SYNB1618 in Healthy Adult Volunteers and Adult Subjects With Phenylketonuria
Status:
Completed
Trial end date:
2019-06-21
Target enrollment:
Participant gender:
Summary
This Phase 1/2a, first-in-human, oral single and multiple dose-escalation, randomized,
double-blinded, placebo-controlled study is evaluating SYNB1618 in healthy volunteers (HV)
and subjects diagnosed with phenylketonuria (PKU), a rare inherited metabolic disorder that
occurs in people who are missing an enzyme that the body needs to use phenylalanine (Phe).
Eligible subjects receive investigational product (IP) in the clinic and undergo safety
monitoring, evaluations, and subsequent follow-up after IP administration.