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 Ph

Study Description

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.

Study Details

Registry ID:

NCT03516487

Conditions:

Phenylketonuria, Healthy

Phase:

Phase 1,Phase 2

Target Enrollment:

70 participants

Start Date:

April 17, 2018

Age Range:

18–64 years

Healthy Volunteers:

No

Study Locations (4 sites)

• Boston Children's Hospital
  Boston, MassachusettsUnited States, United States
• Children's Hospital of Pittsburgh of UPMC
  Pittsburgh, PennsylvaniaUnited States, United States
• Vanderbilt University Medical Center
  Nashville, TennesseeUnited States, United States
• PRA Health Sciences
  Salt Lake City, UtahUnited States, United States

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