Safety, Tolerability and Pharmacodynamics of SYNB1353 in Healthy Adult Volunteers

PHASE1CompletedINTERVENTIONAL
Enrollment

31

Participants

Timeline

Start Date

July 7, 2022

Primary Completion Date

November 27, 2022

Study Completion Date

November 27, 2022

Conditions
Homocystinuria
Interventions
DRUG

SYNB1353

SYNB1353 IMP is formulated as a nonsterile solution intended for oral administration. SYNB1353 is subsequently lyophilized to form the bulk drug product. The lyophilized product is sieved into powder form and filled into high-density polyethylene (HDPE) bottles. Placebo will be manufactured using an inactive powder that is color matched to the SYNB1353 drug product. L-Methionine will be supplied as dry powder and will be suspended in a diluent prior to use.

Trial Locations (1)

27265

High Point Clinical Trials Center, High Point

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Synlogic

INDUSTRY

NCT05462132 - Safety, Tolerability and Pharmacodynamics of SYNB1353 in Healthy Adult Volunteers | Biotech Hunter | Biotech Hunter