CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 21 enrolled
Drug / intervention
LMN-101biological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04098263
NCT04098263Phase 1Completed
CompareCT.gov

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

Lumen Bioscience, Inc.·interventional·Posted Sep 23, 2019·Updated Feb 4, 2025

In Brief

A Phase 1 clinical trial evaluating LMN-101 for Campylobacter Jejuni Infection. Completed, enrolled 21 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCampylobacter Jejuni Infection
CountriesAustralia
Collaborators--

Timeline

Phase 1CompletedFinished
2020202120222023202420252026
First PostedSep 23, 2019
Enrollment StartNov 15, 2019
Primary CompletionApr 15, 2020
Study CompletionJun 24, 2020
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 6.8 years ago

Interventions

LMN-101biological

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