NCT04098263

Safety and Pharmacokinetic Study of LMN-101 in Healthy Volunteers

A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation, Safety and Pharmacokinetic Study of LMN-101 in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Lumen Bioscience, Inc. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed description

Healthy volunteers will be sequentially assigned to the following dosing regimens: Part A: A single, open-label dose of 3000 mg orally (2 subjects) Part B: Subjects will be randomized within a dose regimen to active or placebo treatment: * 300 mg PO TID (three times daily) given as a single 300-mg capsule of LMN-101 orally three times daily for 28 days (4 subjects) or identical-appearing placebo capsule (2 subjects). * 1000 mg PO TID given as two 500-mg capsules of LMN-101 orally three times daily for 28 days (4 subjects) or identical-appearing placebo capsules (2 subjects). * 3000 mg PO TID given as six 500-mg capsules of LMN-101 orally three times daily for 28 days (4 subjects) or identical-appearing placebo capsules (2 subjects). The primary endpoint is: • Safety and tolerability of LMN-101. The secondary endpoints are: * Peak serum drug concentration following administration of the initial dose and peak serum drug concentration following a course of treatment (if systemic absorption is observed). * Area under the serum drug concentration versus time curve (AUC) following administration of the initial dose and following a course of treatment (if systemic absorption is observed). * Induction of serum anti-drug antibodies (if systemic absorption is observed).

Conditions

• Campylobacter Jejuni Infection

Interventions

Type	Name	Description
BIOLOGICAL	LMN-101	variable heavy chain-derived binding protein designed to bind and inhibit flagellin filament protein of Campylobacter jejuni, delivered in whole spray-dried, encapsulated spirulina biomass

Timeline

• Start date: 2019-11-15
• Primary completion: 2020-04-15
• Completion: 2020-06-24
• First posted: 2019-09-23
• Last updated: 2025-02-04
• Results posted: 2024-12-04

Locations

1 site across 1 country: Australia

Regulatory

• FDA-regulated drug study