Investigate the Safety, Tolerability and Pharmacokinetics of FBL-MTX — FolSmart  

Rheumatoid Arthritis Clinical Trial

Official title: Phase 1 Study to Investigate the Safety, Tolerability and Pharmacokinetics of Single-Ascending Doses of FBL-MTX in Healthy Subjects

Status Completed

Clinical Trial Summary

This is a prospective, single-center, randomized, double-blind, placebo-controlled, single-ascending dose (SAD) phase 1 study to evaluate the safety, tolerability and pharmacokinetics of FBL-MTX in healthy male and female subjects.

Clinical Trial Description

The product FBL-MTX consists of Methotrexate (MTX) encapsulating liposomes functionalized with a folate peptide (SP-DS3), which targets activated macrophages of rheumatoid arthritis (RA).

This is a prospective, single-center, randomized, double-blind, placebo-controlled, single-ascending dose (SAD) phase 1 study in healthy subjects.

This study is planned to investigate up to 4 dose levels of FBL-MTX. Each dose level will consist of 8 healthy male and female subjects (ratio 1:1, male:female) to have 6 subjects being administered FBL-MTX and 2 subjects being administered placebo (ratio 3:1, active:placebo).

The study is designed to meet the following objectives:

• Primary: To evaluate the safety and tolerability of FBL-MTX following single-ascending intravenous doses to healthy male and female subjects.

• Secondary: To investigate the PK of FBL-MTX following single-ascending intravenous doses to healthy male and female subjects. ;

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

• NCT number: NCT05117593
• Study type: Interventional
• Source: SOLFARCOS - Pharmaceutical and Cosmetic Solutions Ltd
• Status: Completed
• Phase: Phase 1
• Start date: June 28, 2021
• Completion date: October 19, 2021