MedTrace Logo

LMN-101 in a Campylobacter Human Challenge Model

NCT04182490 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2025-09-25

Study results available
· View outcomes & findings →

Summary

Randomized, double-blind, placebo-controlled, single dose regimen study of LMN-101 followed by Campylobacter jejuni challenge. Subjects will initially, after documentation of informed consent, begin taking their assigned LMN-101 or placebo regimen three times daily. After two days, subjects will receive the C. jejuni challenge inoculum. Subjects will begin an appropriate antibiotic course upon meeting early treatment criteria or 144 hours following C. jejuni challenge, whichever is earlier. Subjects will be allowed to leave the clinical research facility 3 days after antibiotics, when all symptoms have resolved or are resolving, and have had ≥ 2 consecutive stool cultures ≥ 12 hours apart negative for C. jejuni and are afebrile \> 24 hours prior to release and off antipyretics within 24 hours of discharge. Subjects will continue taking their LMN-101 or placebo regimen three times daily for a total of 14 days. Subjects will be provided a diary card/memory aid and thermometer for at-home monitoring of solicited adverse events through Day 24. Subjects will be seen at research facility for protocol-specified evaluations and will also be contacted by telephone 6 months after challenge.

Conditions

  • Campylobacter Infections

Interventions

BIOLOGICAL

LMN-101

VHH-derived binding protein designed to bind and inhibit FlaA, flagellin filament protein of Campylobacter jejuni, delivered in whole spray-dried, spirulina biomass

DRUG

Placebo

Identical appearing placebo

Sponsors & Collaborators

  • Naval Medical Research Center

    collaborator FED

  • Pharmaron

    collaborator INDUSTRY

  • University of Maryland

    collaborator OTHER

  • Lumen Bioscience, Inc.

    lead INDUSTRY

Principal Investigators

  • Mohamed Al-Ibrahim, MB,ChB, FACP · Pharmaron

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-21
Primary Completion
2022-10-04
Completion
2022-10-04
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04182490 on ClinicalTrials.gov