NCT04995653

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

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)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Seres Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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).

Conditions

• Allogeneic Hematopoietic Stem Cell Transplantation

Interventions

Type	Name	Description
DRUG	Vancomycin Pre-Treatment	Four times daily dosing with Vancomycin
DRUG	Vancomycin Placebo	Four times daily dosing with Vancomycin Placebo
DRUG	SER-155	Once daily dosing with SER-155
DRUG	SER-155 Placebo	Once daily dosing with SER-155 placebo

Timeline

• Start date: 2021-11-24
• Primary completion: 2024-07-23
• Completion: 2024-07-23
• First posted: 2021-08-09
• Last updated: 2024-10-01

Locations

13 sites across 1 country: United States

Regulatory

• FDA-regulated drug study