ANT3310 + Meropenem for Drug Metabolism Study

Overseen By J. Burr Ross, MD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Antabio

Must not be taking: Corticosteroids, β-lactam antibiotics

Disqualifiers: Chronic pulmonary disease, Neurological disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how the combination of two drugs, ANT3310 (an experimental treatment) and Meropenem (an antibiotic), moves through the body and assesses their safety when used together. It focuses on healthy adults and requires participants to undergo a procedure that checks the drugs' presence in lung fluid. Ideal candidates are those in good health with no chronic illnesses or allergies to the study drugs. As a Phase 1 trial, participants will be among the first to help researchers understand how this new treatment works in people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the trial is for healthy participants without active or chronic diseases, it's likely that participants should not be on any regular medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that combining ANT3310 with Meropenem (MEM) appears promising in early safety studies. A previous study found that participants tolerated this combination well, with no serious side effects reported. The study aimed to understand the drug's mechanism in the body, which is crucial for ensuring safety.

Additionally, Meropenem is already a commonly used antibiotic, providing some confidence about its safety. ANT3310 has been tested with Meropenem and was well-tolerated in initial trials. These findings suggest that the treatment is generally safe for participants, although ongoing research will provide more detailed information. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about ANT3310 combined with Meropenem because it offers a unique approach to enhancing drug metabolism. Unlike other antibiotics that primarily rely on a single mechanism to fight bacterial infections, ANT3310 is designed to work synergistically with Meropenem, potentially increasing its effectiveness. This combination could lead to faster and more efficient treatment outcomes, providing a new avenue for tackling resistant bacterial strains that don't respond well to existing options.

What evidence suggests that this trial's treatments could be effective?

Research has shown that using ANT3310 with meropenem effectively combats difficult bacterial infections, including carbapenem-resistant A. baumannii and Enterobacterales. ANT3310 blocks enzymes that many bacteria use to resist antibiotics. When combined with meropenem, an antibiotic, this treatment targets a wider range of bacteria. Early results suggest that this combination could be particularly beneficial for serious infections, such as complicated skin infections and bacterial meningitis. ^{2 3 4 6 7}

Who Is on the Research Team?

J. Burr Ross, MD

Principal Investigator

Pulmonary Associates, PA

Are You a Good Fit for This Trial?

This trial is for healthy adult men and women who can undergo a procedure to collect lung fluid. Specific details about eligibility are not provided, but typically participants must meet certain health standards and not have conditions that could interfere with the study or their safety.

Inclusion Criteria

My veins are suitable for IV infusions and blood tests.

Contraceptive use by women or men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies

My BMI is between 18.0 and 32.0, and I weigh more than 50 kg.

Exclusion Criteria

I have a history of epilepsy or significant neurological disorders.

Known severe allergies, non-allergic drug reactions, or multiple drug allergies requiring intranasal or systemic corticosteroids during any time of the year or history of any anaphylactic reaction

History of Gilbert syndrome

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive 3 doses of MEM-ANT3310, infused intravenously over 3 hours every 8 hours

1 day

3 visits (in-person)

Monitoring

Participants undergo bronchoscopy and blood sampling to evaluate pharmacokinetics

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

10 days

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• ANT3310
• Meropenem

Trial Overview The trial is testing how ANT3310 and Meropenem, two drugs, behave in the body when given intravenously. It measures drug levels in blood and lung fluid after a special lung wash procedure done through bronchoscopy.

How Is the Trial Designed?

Group I: ANT3310 and Meropenem (MEM) Experimental Treatment 2 Interventions

Each participant will receive a total of 3 doses of MEM-ANT3310, infused intravenously over 3 hours every 8 hours (i.e., 0 hour, 8 hours, and 16 hours relative to start of the first infusion).

Who Is Running the Clinical Trial?

Antabio

Lead Sponsor

Trials

2

Recruited

120+

Clinartis

Industry Sponsor

Trials

7

Recruited

270+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10916402/

Meropenem-ANT3310, a unique β-lactam-β-lactamase ... This study demonstrates the potent in vitro activity of the MEM-ANT3310 combination against both carbapenem-resistant A. baumannii and ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06916156?term=AREA%5BSponsorSearch%5D(COVERAGE%5BFullMatch%5DEXPANSION%5BNone%5D(%22Clinartis%22))&rank=1

Evaluation of the Concentration of ANT3310 and ... This is an open-label, non-randomized, single-center, repeated i.v. doses, Phase 1 trial to evaluate the pharmacokinetics, safety, and tolerability of a ...

3. withpower.com withpower.com/trial/phase-1-pharmacokinetics-study-on-healthy-volunteers-adults-3-2025-be711

ANT3310 + Meropenem for Drug Metabolism Study It is particularly effective for serious infections like complicated skin infections, intra-abdominal infections, and bacterial meningitis, and it has shown ...

4. researchgate.net researchgate.net/publication/377811600_Meropenem-ANT3310_a_unique_b-lactam-b-lactamase_inhibitor_combination_with_expanded_antibacterial_spectrum_against_Gram-negative_pathogens_including_carbapenem-resistant_Acinetobacter_baumannii

Meropenem-ANT3310, a unique β-lactam-β-lactamase ... This study demonstrates the potent in vitro activity of the MEM-ANT3310 combination against both carbapenem-resistant A. baumannii and Enterobacterales clinical ...

5. synapse.patsnap.com synapse.patsnap.com/drug/7f546b53530740ffa21b2d4a304fb50c

ANT-3310 - Drug Targets, Indications, Patents ANT3310 is a novel broad-spectrum diazabicyclooctane serine β-lactamase inhibitor being developed in combination with meropenem (MEM) for the treatment of ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06527677

Study Details | NCT06527677 | Assessment of the ... This is an open-label, non-randomized, single-center, single iv dose Phase 1 trial to evaluate the pharmacokinetics and safety of a combination of ANT3310 and ...

7. biopharmaapac.com biopharmaapac.com/news/36/5223/antabio-completes-phase-1-trial-of-mem-ant3310-advancing-novel-antibacterial-treatment-for-drug-resistant-infections.html

Antabio Completes Phase 1 Trial of MEM-ANT3310 ... Promising results from Antabio's MEM-ANT3310 trial show excellent tolerability and pharmacokinetics, paving the way for further studies to ...