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A 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 to Evaluate Safety, Tolerability, Kinetics, and Pharmacodynamics

Trial Profile

A 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 to Evaluate Safety, Tolerability, Kinetics, and Pharmacodynamics

Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 03 Jan 2019

At a glance

  • Drugs SYNB-1618 (Primary)
  • Indications Phenylketonuria
  • Focus Adverse reactions; First in man
  • Sponsors Synlogic
  • Most Recent Events

    • 03 Jan 2019 According to a Synlogic media release, company announced positive interim data from the healthy volunteer arm, the data suggested significant effect and a go-forward dose for the treatment arm in patients with PKU.
    • 04 Sep 2018 According to a Synlogic media release, top-line data from the patient treatment arm of this trial is expected in mid-2019 and company plans to present final data from this clinical trial, including data from both healthy volunteers and patients, at an appropriate medical meeting.
    • 04 Sep 2018 Interim results presented in the Synlogic media release.
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