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.
Phase:
Phase 2
Details
Lead Sponsor:
Lumen Bioscience, Inc.
Collaborators:
Naval Medical Research Center Pharmaron University of Maryland