MedTrace Logo

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

NCT04995653 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-10-01

No results posted yet for this study

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

Conditions

  • Allogeneic Hematopoietic Stem Cell Transplantation

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Doris Ponce, MD · MSKCC

  • Bina Tejura, MD · Seres Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-24
Primary Completion
2024-07-23
Completion
2024-07-23
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04995653 on ClinicalTrials.gov