Clinical Trials Logo

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. ;


Study Design


Related Conditions & MeSH terms


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

See also
  Status Clinical Trial Phase
Recruiting NCT04226131 - MusculRA: The Effects of Rheumatoid Arthritis on Skeletal Muscle Biomechanics N/A
Completed NCT04171414 - A Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients With Active Rheumatoid Arthritis Phase 3
Completed NCT02833350 - Safety and Efficacy Study of GDC-0853 Compared With Placebo and Adalimumab in Participants With Rheumatoid Arthritis (RA) Phase 2
Recruiting NCT05112120 - Exploiting Leading Edge 7T MRI Brain Imaging to Decipher Olumiant's Mode of Analgesic Action in Rheumatoid Arthritis
Recruiting NCT04255134 - Biologics for Rheumatoid Arthritis Pain (BIORA-PAIN) Phase 4
Completed NCT03248518 - Lessening the Impact of Fatigue in Inflammatory Rheumatic Diseases N/A
Completed NCT03514355 - MBSR in Rheumatoid Arthritis Patients With Controlled Disease But Persistent Depressive Symptoms N/A
Recruiting NCT05054920 - Eccentric Versus Concentric Exercises for Rotator Cuff Tendinopathy in Patients With Rheumatoid Arthritis N/A
Not yet recruiting NCT05039372 - Rheumatoid Arthritis, Planned Behavıor Theory And Nurse Counselıng N/A
Completed NCT02037737 - Impact and Use of Abatacept IV for Rheumatoid Arthritis in Real Life Setting N/A
Recruiting NCT01087125 - Abatacept Pregnancy Exposure Registry
Recruiting NCT04079374 - Comparative Efficacy, Safety and Immunogenicity Study of Etanercept and Enbrel Phase 3
Completed NCT02504268 - Effects of Abatacept in Patients With Early Rheumatoid Arthritis Phase 3
Recruiting NCT05051943 - A Prospective Observational Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
Recruiting NCT03312465 - Anatomical Shoulder Domelock System Study
Recruiting NCT04169100 - Novel Form of Acquired Long QT Syndrome Phase 4
Completed NCT01942174 - VACcination In Methotrexate Treated Rheumatoid Arthritis Patients Phase 3
Completed NCT03691909 - A Clinical Trial to Determine the Safety and Efficacy of Hope Biosciences Autologous Mesenchymal Stem Cell Therapy (HB-adMSCs) for the Treatment of Rheumatoid Arthritis Phase 1/Phase 2
Completed NCT02139345 - TC-A Registration Study N/A
Recruiting NCT04692493 - RA-PRO PRAGMATIC TRIAL Phase 2