drugset / Trial / NCT05279755
A Study to Evaluate the Safety and Pharmacokinetics of Single and Multiple Doses of Prosetin in Healthy Volunteers and Participants With ALS
Phase 1
Active not recruiting
72 enrolled
ProJenX
Congressionally Directed Medical Research Programs · collab
RandomizedSequentialQuadruple-blindTreatment
Summary
The primary purpose of this study is to evaluate the safety and tolerability of prosetin in healthy volunteers and participants with ALS.
Timeline
- Start
- 2022-02-26
- Primary completion
- 2026-06-30
- Completion
- 2026-10-31
Publications
- Background Thams S, Lowry ER, Larraufie MH, Spiller KJ, Li H, Williams DJ, Hoang P, Jiang E, Williams LA, Sandoe J, Eggan K, Lieberam I, Kanning KC, Stockwell BR, Henderson CE, Wichterle H. A Stem Cell-Based Screening Platform Identifies Compounds that Desensitize Motor Neurons to Endoplasmic Reticulum Stress. Mol Ther. 2019 Jan 2;27(1):87-101. doi: 10.1016/j.ymthe.2018.10.010. Epub 2018 Oct 19.
- Background Bos PH, Lowry ER, Costa J, Thams S, Garcia-Diaz A, Zask A, Wichterle H, Stockwell BR. Development of MAP4 Kinase Inhibitors as Motor Neuron-Protecting Agents. Cell Chem Biol. 2019 Dec 19;26(12):1703-1715.e37. doi: 10.1016/j.chembiol.2019.10.005. Epub 2019 Oct 31.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | prosetin | Unknown | 0.03 mg/kg | Oral |
| Subject | prosetin | Unknown | 0.06 mg/kg | Oral |
| Subject | prosetin | Unknown | 0.1 mg/kg | Oral |
| Subject | prosetin | Unknown | 0.12 mg/kg | Oral |
| Subject | prosetin | Unknown | 0.24 mg/kg | Oral |