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

NCT06527677 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2025-07-29

No results posted yet for this study

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.

Conditions

  • Renal Impairment

Interventions

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.

Sponsors & Collaborators

  • Clinical Research Center Kiel GmbH

    collaborator OTHER

  • Antabio

    lead INDUSTRY

Principal Investigators

  • Christian Zwingelstein, PharmD · Antabio

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2024-07-19
Primary Completion
2025-07-03
Completion
2025-07-10

Countries

  • Germany

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 NCT06527677 on ClinicalTrials.gov