drugset / Trial / NCT04098263
Safety and Pharmacokinetic Study of LMN-101 in Healthy Volunteers
RandomizedParallel-groupQuadruple-blindPrevention
Summary
This will be a randomized, double-blind, placebo-controlled, dose-escalation study of 3 dose levels of LMN-101. Healthy volunteers will take LMN-101 or placebo orally either as a single dose or at one of three dose levels three times daily over 28 days. Protocol-specified evaluations and procedures will be performed on Days 1-2 and every one-two weeks during dosing. Study observation will continue until 4 weeks after the last dose of study drug.
Timeline
- Start
- 2019-11-15
- Primary completion
- 2020-04-15
- Completion
- 2020-06-24
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | LMN-101 | Protein / enzyme biologic | 300 mg | Oral |
| Subject | LMN-101 | Protein / enzyme biologic | 1000 mg | Oral |
| Subject | LMN-101 | Protein / enzyme biologic | 3000 mg | Oral |