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A Multiple Dose Study to Evaluate Safety, Tolerability, PK, and Efficacy of SER-155 in Adults Undergoing HSCT

Allogeneic Hematopoietic Stem Cell Transplantation Clinical Trial

Official title:
A Phase 1b Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of SER-155 in Adults Undergoing Hematopoietic Stem Cell Transplantation (HSCT) to Reduce the Risk of Infection and Graft vs. Host Disease (GvHD)

Clinical Trial Summary

An Open-Label and Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of SER-155 in Adults Undergoing Hematopoietic Stem Cell Transplantation to Reduce the Risk of Infection and Graft vs. Host Disease

Clinical Trial Description

This is a Phase 1b randomized, double-blind, placebo-controlled, multiple dose, multicenter study designed to evaluate the safety, efficacy, and microbiome alterations associated with SER-155 dosing, after microbiome conditioning with oral vancomycin, in adult subjects aged ≥18 years who are undergoing Hematopoietic Stem Cell Transplantation (HSCT). ;

Study Design

Related Conditions & MeSH terms

  • Allogeneic Hematopoietic Stem Cell Transplantation
Clinical Trial Details
NCT number NCT04995653
Study type Interventional
Source Seres Therapeutics, Inc.
Contact
Status Active, not recruiting
Phase Phase 1
Start date November 24, 2021
Completion date October 2024
View Details
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