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

25 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the drug meropenem?

Meropenem is a powerful antibiotic that works well against a wide range of bacteria, including those resistant to other antibiotics. It is particularly effective for serious infections like complicated skin infections, intra-abdominal infections, and bacterial meningitis, and it has shown strong activity against bacteria that produce enzymes making them resistant to many other antibiotics. ^{1 2 3 4 5}

Is the combination of ANT3310 and Meropenem safe for humans?

Meropenem has been used in clinical settings since 1994 and is generally considered safe, with common side effects like diarrhea, rash, and nausea occurring in less than 3% of patients. No unexpected adverse events have been identified, and it is well tolerated in both adults and children. ^{1 6 7 8 9}

What makes the drug ANT3310 + Meropenem unique compared to other treatments?

The combination of ANT3310 with Meropenem is unique because Meropenem is a carbapenem antibiotic that does not require a renal dehydropeptidase-I inhibitor, unlike similar antibiotics, making it potentially less nephrotoxic and neurotoxic. This combination may offer a novel approach to treating infections, especially those resistant to other beta-lactam antibiotics. ^{1 4 5 10 11}

What is the purpose of this trial?

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 combination of MEM-ANT3310 in healthy adult female and male participants who will undergo a single bronchoalveolar lavage (BAL) via a standardized fiberoptic bronchoscopy to evaluate and compare the pharmacokinetics characteristics of ANT3310 and meropenem (MEM) in plasma and epithelial lining luid (ELF).

Research Team

J. Burr Ross, MD

Principal Investigator

Pulmonary Associates, PA

Eligibility Criteria

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.

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

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

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

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)

Treatment Details

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.

Participant Groups

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+

References

1. England pubmed.ncbi.nlm.nih.gov

The pharmacokinetics of meropenem. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Effect of meropenem on disposition kinetics of valproate and its metabolites in rabbits. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Pharmacokinetic and pharmacodynamic properties of meropenem. [2022]

4. France pubmed.ncbi.nlm.nih.gov

[In vitro activity of meropenem and seven other beta-lactam antibiotics against K.pneumoniae and enterobacteriaceae producing beta-lactamases with extended spectrum]. [2018]

5. England pubmed.ncbi.nlm.nih.gov

An isotope-dilution LC-MS/MS method for the simultaneous quantification of meropenem and its open-ring metabolite in serum. [2021]

6. Japan pubmed.ncbi.nlm.nih.gov

[Results of a post-marketing surveillance of meropenem administered over 2 g/day for serious infectious diseases]. [2019]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Meropenem: an updated review of its use in the management of intra-abdominal infections. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Safety profile of meropenem: a review of nearly 5,000 patients treated with meropenem. [2019]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Safety profile of meropenem: an updated review of over 6,000 patients treated with meropenem. [2018]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Meropenem clinical pharmacokinetics. [2018]

11. England pubmed.ncbi.nlm.nih.gov

The disposition and metabolic fate of 14C-meropenem in man. [2018]