drugset / Trial / NCT04098263

Safety and Pharmacokinetic Study of LMN-101 in Healthy Volunteers

NCT04098263 ↗

Phase 1 Completed 21 enrolled Lumen Bioscience, Inc.
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

EvaluationDrugModalityDoseRoute
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

Indications