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

Antabio

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: ANT3310-placebo; Drug: Meropenem; Drug: Meropenem-placebo; Drug: ANT3310

Study type: Interventional

Funder types: Industry

Identifiers

NCT05905913

ANT3310-1001

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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,

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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72 participants in 6 patient groups, including a placebo group

Part A: Single Intravenous Ascending Dose of ANT3310

Experimental group

Treatment:

Drug: ANT3310

Drug: ANT3310

Drug: ANT3310

Part A: Single Intravenous Dose of Matching placebo

Placebo Comparator group

Treatment:

Drug: ANT3310-placebo

Drug: ANT3310-placebo

Drug: ANT3310-placebo

Part B: Multiple Intravenous Ascending Doses of ANT3310

Experimental group

Treatment:

Drug: ANT3310

Drug: ANT3310

Drug: ANT3310

Part B: Multiple Intravenous Ascending Doses of Matching Placebo

Placebo Comparator group

Treatment:

Drug: ANT3310-placebo

Drug: ANT3310-placebo

Drug: ANT3310-placebo

Part C: ANT3310 + Meropenem

Experimental group

Description:

Participants will receive a single intravenous dose of ANT3310 or Meropenem in one of the 2 treatment sequences followed by the repeat administrations of ANT3310 + Meropenem.

Treatment:

Drug: ANT3310

Drug: ANT3310

Drug: Meropenem

Drug: ANT3310

Part C: ANT3310 Placebo + Meropenem Placebo

Placebo Comparator group

Description:

Participants will receive a single dose of ANT3310-placebo or Meropenem-placebo in one of the 2 treatment sequences followed by repeat administrations of ANT3310-placebo + Meropenem-placebo

Treatment:

Drug: ANT3310-placebo

Drug: ANT3310-placebo

Drug: ANT3310-placebo

Drug: Meropenem-placebo