25 Participants Needed

ANT3310 + Meropenem for Drug Metabolism Study

MG
JB
Overseen ByJ. Burr Ross, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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).

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 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.12345

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.26789

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.2671011

Who Is on the Research Team?

JB

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.
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
See 4 more

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
See 10 more

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?
1Treatment groups
Experimental Treatment
Group I: ANT3310 and Meropenem (MEM)Experimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Antabio

Lead Sponsor

Trials
2
Recruited
120+

Clinartis

Industry Sponsor

Trials
7
Recruited
270+

Citations

The pharmacokinetics of meropenem. [2018]
Effect of meropenem on disposition kinetics of valproate and its metabolites in rabbits. [2019]
Pharmacokinetic and pharmacodynamic properties of meropenem. [2022]
[In vitro activity of meropenem and seven other beta-lactam antibiotics against K.pneumoniae and enterobacteriaceae producing beta-lactamases with extended spectrum]. [2018]
An isotope-dilution LC-MS/MS method for the simultaneous quantification of meropenem and its open-ring metabolite in serum. [2021]
[Results of a post-marketing surveillance of meropenem administered over 2 g/day for serious infectious diseases]. [2019]
Meropenem: an updated review of its use in the management of intra-abdominal infections. [2018]
Safety profile of meropenem: a review of nearly 5,000 patients treated with meropenem. [2019]
Safety profile of meropenem: an updated review of over 6,000 patients treated with meropenem. [2018]
Meropenem clinical pharmacokinetics. [2018]
The disposition and metabolic fate of 14C-meropenem in man. [2018]
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