drugset / Trial / NCT05462132
Safety, Tolerability and Pharmacodynamics of SYNB1353 in Healthy Adult Volunteers
RandomizedSequentialTriple-blindTreatment
Summary
This is a Phase 1, double-blind (Sponsor-open), placebo-controlled, randomized, dose-escalation, inpatient study using a multiple-ascending dose (MAD) design to assess the safety, tolerability, and PD of SYNB1353 in HVs.
Timeline
- Start
- 2022-07-07
- Primary completion
- 2022-11-27
- Completion
- 2022-11-27
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SYNB1353 | Cell therapy | 3e+11 cells | Oral |
| Subject | SYNB1353 | Cell therapy | 6e+11 cells | Oral |
| Subject | SYNB1353 | Cell therapy | 1e+12 cells | Oral |
| Subject | SYNB1353 | Cell therapy | 2e+12 cells | Oral |