FiH Study to Assess Safety and PK of SAD and MAD of ANT3310 Alone and in Combination With Meropenem in Healthy Subjects

Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of Single- and Multiple-Ascending Doses of Intravenous ANT3310 Alone and in Combination With Meropenem in Healthy Subjects

The purpose of this study is to evaluate the safety and tolerability of single and multiple intravenous ascending doses of ANT3310, a novel, specific, competitive inhibitor of serine β-lactamases, alone and in combination with meropenem in healthy subjects.

Main Inclusion Criteria:

• Participant capable of giving signed informed consent
• Contraceptive use by women or men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
• Participants are overtly healthy as determined by a medical evaluation including medical history without clinically relevant pathologies, physical examination, vital signs, ECG assessment, and clinical laboratory result
• eGFR ≥ 90 mL/min and < 160 mL/min for males or < 150 mL/min for females
• Body weight within 50.0 and 100.0 kg and BMI within 18.0 and 30.0 kg/m2

Main Exclusion Criteria:

• History of any clinically-relevant gastrointestinal, renal, hepatic, bronchopulmonary, neurological, psychiatric, cardiovascular, endocrine, haematologic, neuromuscular or allergic disease(s), metabolic disorder, cancer, cirrhosis, significant acute infection, local infection within 2 weeks of dose administration,
• ECG: any history of clinically-significant ECG abnormalities, an uninterpretable ECG, or any of ECG abnormalities, unless considered not significant by the Investigator
• Abnormalities in clinical chemical, haematological, or coagulation variables considered medically relevant by the Investigator,
• Positive urine drug screen, positive breathalyzer for alcohol
• Positive results in any of the following virology tests: HIV-1 and -2 antibodies, HBsAg, and anti-hepatitis C virus antibody
• Positive SARS-CoV-2 antigen test
• Women who are pregnant or nursing,
• Donation or loss of over 500 mL of blood within sixty days prior to the first study drug administration,

Part C with co-administration of meropenem:

1. History of epilepsy (or known seizure disorder), brain lesions or other significant neurological disorders,
2. Known history of clinically-significant hypersensitivity or urticaria, or severe allergic reaction to β-lactam antibiotics,
3. History of Gilbert syndrome,
4. History of any severe antibiotic-associated superinfections,