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

NCT05905913 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2024-03-15

No results posted yet for this study

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

Interventions

DRUG

ANT3310

ANT3310 will be infused over 3 hours

DRUG

ANT3310-placebo

ANT3310-placebo will be infused over 3 hours

DRUG

ANT3310

ANT3310 will be infused over 3 hours every 8 hours

DRUG

ANT3310-placebo

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

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.

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.

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.

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.

Sponsors & Collaborators

  • Antabio

    lead INDUSTRY

Principal Investigators

  • Sophie Hays, MD · Biotrial

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-04-12
Primary Completion
2024-01-05
Completion
2024-01-05

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05905913 on ClinicalTrials.gov