SYN-004 for Post-Bone Marrow Transplant Complications

Overseen By Kimberly Reske, MPH

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Synthetic Biologics Inc.

Must be taking: Beta-lactam antibiotics

Disqualifiers: Allergies, Other studies, Liver issues, others

Compensation: Varies

Number of Visits: 30

Duration: 7-9 days

36 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are currently enrolled in another clinical study or have taken an investigational drug recently, you may not be eligible to participate.

What is the purpose of this trial?

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

Eligibility Criteria

Adults over 18 years old undergoing bone marrow transplant for blood disorders who can swallow a capsule and have consented to participate. They must not have severe kidney, heart, liver issues, lung function below 80%, certain infections or bleeding problems, be pregnant/breastfeeding, or allergic to the study drugs.

Inclusion Criteria

Participant is able to ingest the SYN-004 dosage form (size 0 hard capsule)

Participant provides written informed consent

I am 18 or older and will have a stem cell transplant for blood cancer or disorder.

Exclusion Criteria

Pregnant or breast feeding

I started on MER, PIP/TAZO, or FEP before joining this study.

You have had Clostridium difficile infection (CDI) in the past 6 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive SYN-004 or placebo starting on day +1 after HCT until 72 hours after completion of IV antibiotics

7-9 days

Daily monitoring during treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment

365 days

Weekly visits for the first 30 days, then periodic assessments up to 1 year

Treatment Details

Interventions

• SYN-004

Trial Overview The trial is testing SYN-004's safety and its effects on gut bacteria in patients receiving bone marrow transplants who develop fevers treated with specific IV antibiotics. It also looks at how well SYN-004 enters the bloodstream and interacts with these antibiotics.

Participant Groups

Group I: SYN-004 + IV Meropenem Active Control 1 Intervention

SYN-004, oral administration, 150mg, 4 times per day (q6h), beginning on day +1 after HCT until 72-hours after completion of IV Meropenem (MER)

Group II: SYN-004 + IV Piperacillin/Tazobactam Active Control 1 Intervention

SYN-004, oral administration, 150mg, 4 times per day (q6h), beginning on day +1 after HCT until 72-hours after completion of IV Piperacillin/Tazobactam (PIP/TAZO)

Group III: SYN-004 + Cefepime Active Control 1 Intervention

SYN-004, oral administration, 150mg, 4 times per day (q6h), beginning on day +1 after HCT until 72-hours after completion of IV Cefepime (FEP)

Group IV: Placebo + IV Meropenem Placebo Group 1 Intervention

Placebo, oral administration, 4 times per day (q6h), beginning on day +1 after HCT until 72-hours after completion of IV Meropenem (MER)

Group V: Placebo + IV Piperacillin/Tazobactam Placebo Group 1 Intervention

Placebo, oral administration, 4 times per day (q6h), beginning on day +1 after HCT until 72-hours after completion of IV Piperacillin/Tazobactam (PIP/TAZO)

Group VI: Placebo + IV Cefepime Placebo Group 1 Intervention

Placebo, oral administration, 4 times per day (q6h), beginning on day +1 after HCT until 72-hours after completion of IV Cefepime (FEP)

Who Is Running the Clinical Trial?

Synthetic Biologics Inc.

Lead Sponsor

Trials

9

Recruited

720+

Theriva Biologics, Inc.

Lead Sponsor

Trials

9

Recruited

720+

Washington University School of Medicine

Collaborator

Trials

2,027

Recruited

2,353,000+