Safety and Tolerability of SYNB1618 in Healthy Adult Volunteers and Adult Subjects With Phenylketonuria

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

April 17, 2018

Primary Completion Date

June 21, 2019

Study Completion Date

June 21, 2019

Conditions
PhenylketonuriaHealthy
Interventions
DRUG

SYNB1618

SYNB1618 is supplied in a buffered solution in 5 mL polypropylene cryovials with a nominal 5 mL fill volume, administered with 100 mL of masking buffer solution.

DRUG

Placebo

Subjects receive placebo orally in a chilled buffered solution (100 mL).

Trial Locations (4)

15224

Children's Hospital of Pittsburgh of UPMC, Pittsburgh

37232

Vanderbilt University Medical Center, Nashville

84124

PRA Health Sciences, Salt Lake City

02115

Boston Children's Hospital, Boston

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Synlogic

INDUSTRY

NCT03516487 - Safety and Tolerability of SYNB1618 in Healthy Adult Volunteers and Adult Subjects With Phenylketonuria | Biotech Hunter | Biotech Hunter