NCT06527677

Assessment of the Pharmacokinetics and Safety of ANT3310 Combined With Meropenem in Renally Impaired Subjects

Phase 1, Open-Label, Non-Randomized, Single-Center, Single-Dose Study to Assess the Pharmacokinetics & Safety of ANT3310 Combined With Meropenem Administered as a Single Intravenous Infusion to Adult Subjects With Renal Function Impairment

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Antabio · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

This is an open-label, non-randomized, single-center, single i.v. dose Phase 1 trial to evaluate the pharmacokinetics and safety of a combination of ANT3310 and meropenem in participants with different degrees of renal function impairment, including participants with End-Stage Renal Disease (ESRD), compared with matching control participants with normal renal function.

Detailed description

The participants will receive 1 single dose of the combination of ANT3310 and meropenem (2 times a single dose in participants with ESRD).

Conditions

• Renal Impairment

Interventions

Type	Name	Description
DRUG	ANT3310	ANT3310 will be administered as a single intravenous infusion over 3 hours at a constant rate.
DRUG	Meropenem	meropenem will be administered as a single intravenous infusion over 3 hours at a constant rate.

Timeline

• Start date: 2024-07-19
• Primary completion: 2025-07-03
• Completion: 2025-07-10
• First posted: 2024-07-30
• Last updated: 2025-07-29

Locations

1 site across 1 country: Germany