NCT05905913

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Antabio · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2023-04-12
• Primary completion: 2024-01-05
• Completion: 2024-01-05
• First posted: 2023-06-15
• Last updated: 2024-03-15

Locations

1 site across 1 country: France