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

Phase 1

Recruiting

• Conditions: Renal Impairment

• Registration Number: NCT06527677
• Lead Sponsor: Antabio

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-7-8
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Main Inclusion Criteria:<br><br> - Participant must be 18 to 80 years of age (both inclusive) at the time of signing<br> the informed consent.<br><br> - BMI within the range of 18.0 to 36.0 kg/m2 (both inclusive) with a body weight = 50<br> kg.<br><br> - Contraceptive use by women or men should be consistent with local regulations<br> regarding the methods of contraception for those participating in clinical studies.<br><br> - Capable of giving signed informed consent in compliance with the requirements and<br> restrictions listed in the ICF and in the protocol.<br><br> - Ability to cooperate with the investigator and to comply with the requirements of<br> the trial.<br><br> - Sufficient venous access for i.v. infusion and PK samplings.<br><br> - For participants with renal function impairment: Individualized eGFR <90 mL/min at<br> screening, estimated according to the individualized CKD-EPI equation and stable<br> renal function.<br><br> - For participants with ESRD requiring dialysis: Chronic intermittent hemodialysis for<br> =3 months prior to dosing.<br><br> - For participants with normal renal function: Individualized eGFR =90 mL/min at<br> screening, estimated based on serum creatinine measured within 10 days prior to Day<br> -1 according to the CKD-EPI equation.<br><br>Main Exclusion Criteria:<br><br> - Febrile illness within 1 week before admission to the study center.<br><br> - Known hypersensitivity to meropenem and or ANT3310 or any of the excipients of the<br> infusion solution.<br><br> - Known severe allergies, non-allergic drug reactions, or multiple drug allergies<br> requiring intranasal or systemic corticosteroids during any time of the year or<br> history of any anaphylactic reaction.<br><br> - Medical disorder, condition, or history of such that would - in the opinion of the<br> investigator - compromise the participant's ability to participate in this study.<br><br> - History of epilepsy (or known seizure disorder), brain lesions or other significant<br> neurological disorders.<br><br> - Known history of clinically significant hypersensitivity or urticaria, or severe<br> allergic reaction to ß-lactam antibiotics (e.g., penicillin, cephalosporin,<br> carbapenem, or monobactam).<br><br> - History of Gilbert syndrome.<br><br> - History of any severe antibiotic-associated superinfections like Clostridium<br> difficile colitis and/or frequent fungal vaginal infections.<br><br> - Therapies (e.g., physiotherapy, acupuncture, etc.) within 1 week before study drug<br> administration.<br><br> - Positive results for HBsAg, anti-HCV, HIV antibodies (anti-HIV 1+2).<br><br> - For participants with impaired renal function: Acute renal failure or active renal<br> infections, Clinically significant impaired hepatic function, Severe infection or<br> any clinically significant illness within 4 weeks before dosing, Impairment of any<br> other major organ system other than the kidney except underlying disease, Diagnosed<br> malignancy during the past 5 years except completely resected basal cell cancer of<br> the skin, Any kidney transplant during the last 10 years, any other organ transplant<br> during the past 5 years.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified