Assessment of the Pharmacokinetics and Safety of ANT3310 Combined With Meropenem in Renally Impaired Subjects

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 is an open-label, non-randomized, single-center, single i.v. dose Phase 1 trial to evaluate the pharmacokinetics and safety of a combination of ANT3310 and meropenem in participants with different degrees of renal function impairment, including participants with End-Stage Renal Disease (ESRD), compared with matching control participants with normal renal function.

The participants will receive 1 single dose of the combination of ANT3310 and meropenem (2 times a single dose in participants with ESRD).

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.