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

NCT ID: NCT05905913

Last Updated: 2024-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-12
• Study Completion Date: 2024-01-05

Brief Summary

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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: QUADRUPLE

Study Groups

Part A: Single Intravenous Ascending Dose of ANT3310

Group Type: EXPERIMENTAL

ANT3310

Intervention Type: DRUG

ANT3310 will be infused over 3 hours

Part A: Single Intravenous Dose of Matching placebo

Group Type: PLACEBO_COMPARATOR

ANT3310-placebo

Intervention Type: DRUG

ANT3310-placebo will be infused over 3 hours

Part B: Multiple Intravenous Ascending Doses of ANT3310

Group Type: EXPERIMENTAL

ANT3310

Intervention Type: DRUG

ANT3310 will be infused over 3 hours every 8 hours

Part B: Multiple Intravenous Ascending Doses of Matching Placebo

Group Type: PLACEBO_COMPARATOR

ANT3310-placebo

Intervention Type: DRUG

ANT3310-placebo will be infused over 3 hours every 8 hours

Part C: ANT3310 + Meropenem

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.

Group Type: EXPERIMENTAL

ANT3310

Intervention Type: DRUG

ANT3310 will be infused over 3 hours as a single dose as part of the drug-drug interaction study, then every 8 hours as part of the repeat doses study.

Meropenem

Intervention Type: DRUG

Meropenem will be infused over 3 hours as a single dose as part of the drug-drug interaction study, then every 8 hours as part of the repeat doses study.

Part C: ANT3310 Placebo + Meropenem Placebo

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

Group Type: PLACEBO_COMPARATOR

ANT3310-placebo

Intervention Type: DRUG

ANT3310-placebo will be infused over 3 hours as a single dose as part of the drug drug interaction study, then every 8 hours as part of the repeat doses study.

Meropenem-placebo

Intervention Type: DRUG

Meropenem-placebo will be infused over 3 hours as a single dose as part of the drug-drug interaction study, then every 8 hours as part of the repeat doses study.

Interventions

ANT3310

ANT3310 will be infused over 3 hours

Intervention Type: DRUG

ANT3310-placebo

ANT3310-placebo will be infused over 3 hours

Intervention Type: DRUG

ANT3310

ANT3310 will be infused over 3 hours every 8 hours

Intervention Type: DRUG

ANT3310-placebo

ANT3310-placebo will be infused over 3 hours every 8 hours

Intervention Type: DRUG

ANT3310-placebo

ANT3310-placebo will be infused over 3 hours as a single dose as part of the drug drug interaction study, then every 8 hours as part of the repeat doses study.

Intervention Type: DRUG

ANT3310

ANT3310 will be infused over 3 hours as a single dose as part of the drug-drug interaction study, then every 8 hours as part of the repeat doses study.

Intervention Type: DRUG

Meropenem

Meropenem will be infused over 3 hours as a single dose as part of the drug-drug interaction study, then every 8 hours as part of the repeat doses study.

Intervention Type: DRUG

Meropenem-placebo

Meropenem-placebo will be infused over 3 hours as a single dose as part of the drug-drug interaction study, then every 8 hours as part of the repeat doses study.

Intervention Type: DRUG

Eligibility Criteria

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

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,

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Antabio

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sophie Hays, MD

Role: PRINCIPAL_INVESTIGATOR

Biotrial

Locations

Biotrial

Rennes, , France

Countries

France

Other Identifiers

ANT3310-1001

Identifier Type: -

Identifier Source: org_study_id