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A Clinical Trial of ALE.F02 in Patients With Advanced Liver Fibrosis and/or With Mild Cirrhosis

NCT05939947 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2024-12-03

No results posted yet for this study

Summary

The purpose of this study is to evaluate how a human body processes ALE.F02 (pharmacokinetics profile) in patients with impaired liver function.

Conditions

Interventions

DRUG

ALE.F02

Continuous intravenous (IV) infusion administered once every second week to a total of 3 doses.

DRUG

Placebo

Continuous intravenous (IV) infusion administered once every second week to a total of 3 doses.

Sponsors & Collaborators

  • Alentis Therapeutics AG

    lead INDUSTRY

Principal Investigators

  • Luigi Manenti, MD · Alentis Therapeutics AG

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-01
Primary Completion
2024-10-30
Completion
2024-10-30
FDA Drug
Yes

Countries

  • United States
  • Germany
  • Romania
  • Slovakia

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT05939947 on ClinicalTrials.gov