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Clinical Trial Summary

This study will evaluate SYNB1618 (investigational product) in healthy volunteers (HV) and subjects diagnosed with phenylketonuria (PKU) for the possible treatment of PKU. Phenylketonuria (PKU) is a rare inherited metabolic disorder that occurs in people who are missing an enzyme that the body needs to use phenylalanine. Eligible subjects will receive investigational product (IP) in the clinic, and will undergo safety monitoring, evaluations and subsequent follow-up after IP administration.

Clinical Trial Description

This Phase 1/2a, first-in-human, oral single and multiple dose-escalation, randomized, double-blinded, placebo-controlled study of SYNB1618 in healthy adult volunteers and adult subjects with phenylketonuria will evaluate safety, tolerability, kinetics, and pharmacodynamics within the following 2 study parts:

Part 1 comprises a single-ascending dose (SAD) study conducted (3 treated:1 placebo) over 4 days in HV male and female subjects evaluated in up to 6 dose cohorts to identify maximum tolerated dose (MTD) within the single dose-dose range studied. Up to 24 healthy subjects may be enrolled in this part of the study. Following attainment of the MTD in HV, a SAD cohort of up to 4 subjects (male and female, >18 years old) previously diagnosed with PKU will be enrolled (3 treated:1 placebo).

Part 2 comprises a multiple-ascending dose (MAD) study conducted in an inpatient setting (6 treated:2 placebo) over 10 days in HV male and female subjects evaluated in up to 4 cohorts at doses that will not exceed the MTD from the SAD part of the study to identify the MTD of SYNB1618 within the multiple-dose range studied. Up to 32 healthy subjects may be enrolled in this part of the study. Once the highest MAD cohort and the SAD PKU cohort have been completed, a multiple-dose cohort of male and female subjects (>18 years old) previously diagnosed with PKU will be evaluated. Up to 20 subjects with PKU may be enrolled in the MAD PKU cohort (12 treated: 8 placebo). ;

Study Design

Related Conditions & MeSH terms

NCT number NCT03516487
Study type Interventional
Source Synlogic
Contact Kendall Davis
Phone 919-788-6519
Status Recruiting
Phase Phase 1/Phase 2
Start date April 2, 2018
Completion date September 2019

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