drugset / Trial / NCT05117593
Investigate the Safety, Tolerability and Pharmacokinetics of FBL-MTX
RandomizedSequentialQuadruple-blindOther
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.
Timeline
- Start
- 2021-06-28
- Primary completion
- 2021-10-19
- Completion
- 2021-10-19
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Methotrexate | Small molecule | 0.1 mg | Intravenous |
| Subject | Methotrexate | Small molecule | 0.33 mg | Intravenous |
| Subject | Methotrexate | Small molecule | 1 mg | Intravenous |
| Subject | Methotrexate | Small molecule | 2.5 mg | Intravenous |