SYN-004 Safety and Tolerability in Allo-HCT Subjects

Running, not enrolling · Phase 1/Phase 2 · Has a placebo group

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

In brief

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

Key facts

Study ID

NCT04692181

Run by

Theriva Biologics, Inc.

People needed

36

Starts

2021-02-15

Expected to finish

2030-09-30

Last updated by the study team

2026-03-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant provides written informed consent.
• Male or female patients ≥18 years undergoing myeloablative allo-HCT for a hematologic malignancy or myeloproliferative disorder.
• Participant is able to ingest the SYN-004 dosage form (size 0 hard capsule).

You may not qualify if…

• Allergy(ies) to MER, PIP, TAZO, or FEP.
• History of allergy to SYN-004 or its components.
• Admitted for HCT and started on MER, PIP/TAZO, or FEP prior to enrollment in the present study.
• Currently enrolled in another interventional clinical study or received an investigational drug or device within 30 days or within a time period consistent with a washout period of 5 half-lives before signing the Informed Consent Form, whichever is longer.
• Recipients of umbilical cord blood transplantation.
• Underlying condition requiring HCT is not in remission (per International Working Group definitions), except for myelodysplastic syndrome and lymphoma, as long as these conditions are chemotherapy responsive.
• Creatinine clearance <60 mL/min/1.73 m² by Cockroft-Gault calculation.
• Cardiac ejection fraction <50%.
• Cirrhosis, bilirubin >1.5x upper limit of normal, or AST/ALT >2.5x upper limit of normal.
• History of veno-occlusive disease (VOD) or hepatic sinusoidal obstructive syndrome (SOS).
• DLCO and/or FEV1 ≤80% of normal.
• Chronic HIV or HBV infection.
• Invasive fungal infection not responding to treatment at time of HCT.
• Known active bacterial or viral infection at time of HCT.
• CDI in the preceding 6 months.
• Unable to comply with study protocol as determined by primary investigator.
• Active gastrointestinal (GI) bleeding at time of HCT.
• Prior colectomy or short gut syndrome.
• Pregnant or breast feeding.

Where it is running

• Washington University — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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