Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04995653 | A Multiple Dose Study to Evaluate Safety, Tolerability, PK, and Efficacy of SER-155 in Adults Undergoing HSCT | PHASE1 | COMPLETED | 60 | — | — | Nov 24, 2021 | Jul 23, 2024 | Oct 1, 2024 | 13 | United States |
Incidence and severity of participants with adverse events, serious adverse events, or adverse events of special interest
Prevalence of SER-155 strains in subject stool measured before and after treatment courses
| Arm | Type | Description |
|---|---|---|
| Cohort 1 - Open Label Study | EXPERIMENTAL | Vancomycin \& SER-155 |
| Cohort 2 - Randomized, Double-Blind, Placebo-Controlled Study | EXPERIMENTAL | Vancomycin \& SER-155 OR Vancomycin placebo \& SER-155 placebo |
| Name | Type | Description |
|---|---|---|
| Vancomycin Pre-Treatment | DRUG | Four times daily dosing with Vancomycin |
| Vancomycin Placebo | DRUG | Four times daily dosing with Vancomycin Placebo |
| SER-155 | DRUG | Once daily dosing with SER-155 |
| SER-155 Placebo | DRUG | Once daily dosing with SER-155 placebo |
Inclusion Criteria: * Male and female subjects ≥ 18 years of age undergoing HSCT. * Planning to undergo allogeneic hematopoietic stem cell transplantation from a human leukocyte antigen matched related donor, haploidentical related donor, HLA-matched unrelated donor, or HLA 1-antigen mismatched unr...