Evaluating the safety and pharmacokinetics of ANT3310 with meropenem in patients with kidney impairment

Phase 1, Open-Label, Non-Randomized, Single-Center, Single-Dose Study to Assess the Pharmacokinetics & Safety of ANT3310 Combined With Meropenem Administered as a Single Intravenous Infusion to Adult Subjects With Renal Function Impairment

This study is testing how safe and effective a new drug combination is for people with kidney problems, including those with severe kidney disease, compared to those with normal kidney function.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Antabio (Industry-sponsored)
• Locations: 1 site (Kiel)
• Trial ID: NCT06527677 on ClinicalTrials.gov

What this trial studies

This open-label, non-randomized Phase 1 trial assesses the pharmacokinetics and safety of a combination of ANT3310 and meropenem in individuals with varying degrees of renal impairment, including those with End-Stage Renal Disease (ESRD). Participants will receive a single intravenous dose of the drug combination, with ESRD patients receiving double the dose. The study aims to compare the effects in these patients against a control group with normal renal function. The trial is conducted at a single center, focusing on understanding how renal impairment affects drug metabolism and safety.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 80 with varying degrees of renal function impairment, including those on dialysis.

Not a fit: Patients with normal renal function or those outside the specified age and BMI criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to safer and more effective treatment options for patients with renal impairment.

How similar studies have performed: Other studies have explored pharmacokinetics in renal impairment, but this specific combination is novel and has not been extensively tested.

Eligibility criteria

Main Inclusion Criteria:

* Participant must be 18 to 80 years of age (both inclusive) at the time of signing the informed consent.
* BMI within the range of 18.0 to 36.0 kg/m2 (both inclusive) with a body weight ≥ 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.
* Capable of giving signed informed consent in compliance with the requirements and restrictions listed in the ICF and in the protocol.
* Ability to cooperate with the investigator and to comply with the requirements of the trial.
* Sufficient venous access for i.v. infusion and PK samplings.
* For participants with renal function impairment: Individualized eGFR \<90 mL/min at screening, estimated according to the individualized CKD-EPI equation and stable renal function.
* For participants with ESRD requiring dialysis: Chronic intermittent hemodialysis for ≥3 months prior to dosing.
* For participants with normal renal function: Individualized eGFR ≥90 mL/min at screening, estimated based on serum creatinine measured within 10 days prior to Day -1 according to the CKD-EPI equation.

Main Exclusion Criteria:

* Febrile illness within 1 week before admission to the study center.
* Known hypersensitivity to meropenem and or ANT3310 or any of the excipients of the infusion solution.
* 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.
* 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.
* History of epilepsy (or known seizure disorder), brain lesions or other significant neurological disorders.
* Known history of clinically significant hypersensitivity or urticaria, or severe allergic reaction to β-lactam antibiotics (e.g., penicillin, cephalosporin, carbapenem, or monobactam).
* History of Gilbert syndrome.
* History of any severe antibiotic-associated superinfections like Clostridium difficile colitis and/or frequent fungal vaginal infections.
* Therapies (e.g., physiotherapy, acupuncture, etc.) within 1 week before study drug administration.
* Positive results for HBsAg, anti-HCV, HIV antibodies (anti-HIV 1+2).
* For participants with impaired renal function: Acute renal failure or active renal infections, Clinically significant impaired hepatic function, Severe infection or any clinically significant illness within 4 weeks before dosing, Impairment of any other major organ system other than the kidney except underlying disease, Diagnosed malignancy during the past 5 years except completely resected basal cell cancer of the skin, Any kidney transplant during the last 10 years, any other organ transplant during the past 5 years.

Where this trial is running

Kiel

• CRS Clinical Research Services Kiel GmbH — Kiel, Germany (Recruiting)

Study contacts

• Study coordinator: Atef Halabi, Dr

Conditions Renal Impairment