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NCT04182490 · ClinicalTrials.gov registry record · Phase 2
LMN-101 in a Campylobacter Human Challenge Model
A Phase 2 study, sponsored by Lumen Bioscience.
- Completed
- Registry status
- Phase 2
- Development phase
- 42
- Enrollment target
NCT04182490 is a Phase 2 study that has completed, run by Lumen Bioscience. The registered enrollment target is 42 participants.
The verdict
NCT04182490, a Phase 2 study, has completed, sponsored by Lumen Bioscience.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 42 participants
- Enrollment target
Study 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.
Interventions
- DRUG Placebo
- BIOLOGICAL LMN-101
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2022-02-21 |
| Est. Completion | 2022-10-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04182490
The ClinicalTrials.gov registry entry for NCT04182490 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Lumen Bioscience, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04182490 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04182490 about?
NCT04182490 is a clinical study titled "LMN-101 in a Campylobacter Human Challenge Model". 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 rec...
What is the current status of trial NCT04182490?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 42 participants. The study started on 2022-02-21. Estimated completion is 2022-10-04.
What interventions are being tested in trial NCT04182490?
The interventions under investigation include: Placebo (DRUG), LMN-101 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04182490?
This trial is sponsored by Lumen Bioscience, which has 2 total clinical trials registered on ClinicalTrials.gov.
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