Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:07 AM
Ignite Modification Date:
2025-12-25 @ 1:07 AM
NCT ID:
NCT05117593
Brief 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.
Detailed 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.
Study:
NCT05117593
Study Brief:
Protocol Section:
NCT05117593