SYN-004 Safety and Tolerability in Allo-HCT Subjects

Study Summary

Study Objectives: 1. To evaluate the safety and tolerability of oral SYN-004 in adult allogeneic HCT (allo-HCT) recipients who develop fever after conditioning therapy and are treated with IV β-lactam antibiotics meropenem (MER), piperacillin tazobactam (PIP/TAZO), or cefepime (FEP). 2. To evaluate potential absorption of oral SYN-004 into the systemic circulation of allo-HCT recipients and potential SYN-004-mediated alterations to systemic levels and efficacy of IV MER, PIP/TAZO or FEP. 3. To evaluate potential protective effects of SYN-004 on the intestinal microbiome of allo-HCT recipients treated with IV MER, PIP/TAZO or FEP. 4. To obtain preliminary information on potential therapeutic benefits and patient outcomes of SYN-004 in allo-HCT recipients treated with IV MER, PIP/TAZO or FEP

Conditions

Acute Graft-Versus-Host Reaction Following Bone Marrow Transplant Prevention of CDI in Adult Patients Being Treated With IV Beta-lactam Antibiotics

Interventions / Drugs

SYN-004, Ribaxamase or Placebo

View on ClinicalTrials.gov ↗

Sponsor

TOVX

Theriva Biologics, Inc.

Biotech / Pharma

D36/100

Study Details

Enrollment36 participants

Primary Completion—

Lead SponsorTheriva Biologics, Inc.

Data Retrieved2026-06-17 02:58:33.773498+00:00

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