NCT05117593

Investigate the Safety, Tolerability and Pharmacokinetics of FBL-MTX

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: SOLFARCOS - Pharmaceutical and Cosmetic Solutions Ltd · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	FBL-MTX	FBL-MTX is available as sterile liposomal dispersion for injection at nominal dose strength of 1 mg/mL of methotrexate free base. The dose of 0.1 mg was selected as starting dose in the present study. Three subsequent FBL-MTX dose levels are pre-planned: 0.33 mg, 1 mg and 2.5 mg.
DRUG	Placebo	Placebo will consist of sterile saline 0.9% NaCl solution.

Timeline

• Start date: 2021-06-28
• Primary completion: 2021-10-19
• Completion: 2021-10-19
• First posted: 2021-11-11
• Last updated: 2021-11-22

Locations

1 site across 1 country: Portugal