Ignite Creation Date:
2024-05-06 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 2:17 PM
Study NCT ID:
NCT05117593
Status:
COMPLETED
Last Update Posted:
2021-11-22
First Post:
2021-09-23
Brief Title:
Investigate the Safety Tolerability and Pharmacokinetics of FBL-MTX
Sponsor:
SOLFARCOS - Pharmaceutical and Cosmetic Solutions Ltd
Organization:
SOLFARCOS - Pharmaceutical and Cosmetic Solutions Ltd
Study Overview
Official Title:
Phase 1 Study to Investigate the Safety Tolerability and Pharmacokinetics of Single-Ascending Doses of FBL-MTX in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2021-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FolSmart
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 11 malefemale to have 6 subjects being administered FBL-MTX and 2 subjects being administered placebo ratio 31 activeplacebo
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
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 11 malefemale to have 6 subjects being administered FBL-MTX and 2 subjects being administered placebo ratio 31 activeplacebo
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None