Evaluating the concentration of ANT3310 and Meropenem in the lungs of healthy adults

A Phase 1, Open-Label, Single Center Study to Determine the Penetration of ANT3310 and Meropenem Into the Lung After Repeated Intravenous Administrations of MEM-ANT3310 in Healthy Adult Participants

This study is testing how well a new drug combination works in the lungs of healthy adults to see if it's safe and how the body handles it.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Antabio (Industry-sponsored)
• Locations: 1 site (Phoenix, Arizona)
• Trial ID: NCT06916156 on ClinicalTrials.gov

What this trial studies

This open-label, non-randomized Phase 1 trial aims to assess the pharmacokinetics, safety, and tolerability of a combination of ANT3310 and meropenem in healthy adult participants. A total of 25 participants will receive three intravenous doses of MEM-ANT3310, followed by a bronchoalveolar lavage (BAL) to analyze drug concentrations in plasma and epithelial lining fluid. Participants will be closely monitored for any adverse events throughout the study duration.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy adults aged 18 to 55 with a BMI between 18.0 and 32.0 kg/m2.

Not a fit: Patients with active or chronic diseases or those outside the specified age and BMI range may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance our understanding of drug distribution in the lungs, potentially leading to improved treatments for respiratory infections.

How similar studies have performed: While pharmacokinetics studies are common, this specific combination and approach may offer novel insights into lung drug concentrations.

Eligibility criteria

Inclusion Criteria:

* Capable of giving signed informed consent in compliance with the requirements and restrictions listed in the ICF and in the protocol.
* Participants must be 18 to 55 years of age, both inclusive, at the time of signing the informed consent.
* Body mass index (BMI) within the range 18.0-32.0 kg/m2 (both inclusive) and body weight \> 50.0 kg (110 Ibs) at Screening.
* Contraceptive use by women or men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
* Healthy participants as defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, 12-lead ECG, vital signs, physical examination, spirometry at Screening (FEV1 \> 80% of predicted), and clinical laboratory tests at Screening and Day -1.
* Healthy participants with vital signs at Screening and Day -1 within the normal ranges: tympanic body temperature: ≥ 35.5°C and ≤ 37.5°C; resting pulse rate ≥ 50 beats per minute (bpm) and ≤ 100 bpm; systolic blood pressure (SBP) ≥ 90 and ≤ 139 mmHg, diastolic blood pressure (DBP) ≥ 50 and ≤ 89 mmHg, taken in supine position after resting at least 5 minutes. On Day -1, blood pressure and pulse rate need to be within the normal ranges or not clinically significant range, as per investigator's judgement.
* Individualized estimated glomerular filtration rate (eGFR): \[(CKD-EPI ÷ 1.73) × BSA\] ≥ 90 mL/min and \< 160 mL/min for males or \< 150 mL/min for females at Screening.
* Sufficient venous access for i.v. infusion and PK samplings.

Exclusion Criteria:

* History of any clinically relevant gastrointestinal, renal, hepatic, bronchopulmonary, neurological, psychiatric, cardiovascular, endocrine, hematologic, neuromuscular or allergic disease(s), metabolic disorder, cancer (may have had basal or squamous cell carcinoma of skin or cervix so long as surgically removed or deemed cured by cryotherapy, laser therapy, conization, etc, with stability for the past two years).
* History or presence of chronic pulmonary disease.
* Medical disorder, condition, or history of such that would - in the opinion of the Investigator - compromise the participant's ability to participate in this study.
* Presence of any acute illness, including febrile illness with temperature \> 37.8°C (\> 100.0°F), within 7 days of Baseline (Day -1 to Day 1).
* 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.
* Known hypersensitivity to meropenem and or ANT3310 or any of the excipients of the infusion solution.
* Known history of clinically significant hypersensitivity or urticaria, or severe allergic reaction to β-lactam antibiotics (i.e., penicillin, cephalosporin, carbapenem, or monobactam).
* History of significant bleeding within the past 3 months.
* History of COVID-19 within three (3) months prior to Screening.
* History of epilepsy (or known seizure disorder), brain lesions or other significant neurological disorders.
* History of Gilbert syndrome.
* History of any severe antibiotic-associated superinfections, such as Clostridium difficile colitis and/or frequent fungal vaginal infections.
* Contraindications to bronchoalveolar lavage or suspected intolerability to medications necessary for bronchoscopy, hypoxemia, reactive airway disease or asthma, unstable angina or acute myocardial infarction in the last 6 months, heart failure, and severe hemostatic alterations. Anatomical or anticipated technical difficulties that would prevent bronchoscopy or BAL procedure. Allergies to lidocaine.

Where this trial is running

Phoenix, Arizona

• Pulmonary Associates, PA — Phoenix, Arizona, United States (Recruiting)

Study contacts

• Principal investigator: J. Burr Ross, MD — Pulmonary Associates, PA
• Study coordinator: Mark Gotfried, MD

Conditions Pharmacokinetics Study on Healthy Volunteers Adults; healthy volunteers; Bronchoalveolar lavage study