Status:
COMPLETED
Assessment of the Pharmacokinetics and Safety of ANT3310 Combined With Meropenem in Renally Impaired Subjects
Lead Sponsor:
Antabio
Collaborating Sponsors:
Clinical Research Center Kiel GmbH
Conditions:
Renal Impairment
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief Summary
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 differen...
Detailed Description
The participants will receive 1 single dose of the combination of ANT3310 and meropenem (2 times a single dose in participants with ESRD).
Eligibility Criteria
Inclusion
- Main
- 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
- 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.
Key Trial Info
Start Date :
July 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 10 2025
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT06527677
Start Date
July 19 2024
End Date
July 10 2025
Last Update
July 29 2025
Active Locations (1)
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1
CRS Clinical Research Services Kiel GmbH
Kiel, Germany, D-24105