Campylobacter InfectionsPhase 2NCT04182490
LMN-101 in a Campylobacter Human Challenge Model
A Phase 2 study testing LMN-101 in people with Campylobacter Infections, run by Lumen Bioscience, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Campylobacter Infections
- What is being tested?
- LMN-101
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2022to 4 Oct 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or non-pregnant female between 18 and 50 years of age, inclusive, at time of informed consent
- Willingness to participate after written informed consent obtained
- Available for all planned clinical visits (for physical examinations, blood draws, and stool collections) and follow-up monitoring (9 or 10 clinic visits and 1 phone interview 6 months post-challenge)
- Agreement to follow the restrictions of the study. Willing and able to follow the study directions and procedures, including the rules and procedures of the clinical research unit.
- Demonstrated comprehension of the protocol procedures including knowledge of Campylobacter illness by passing a written examination (passing grade ≥ 70%).
- General good health, without significant medical illness or abnormal physical examination findings as determined by the PI.
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- Laboratory values are Grade 1 or lower using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 as defined below:
- Absolute neutrophil count ≥ 1500/μL
- Lymphocyte count ≥ 800/μL
- Platelet count ≥ 125,000/μL
- Hemoglobin ≥ 13.0 g/dL in males (≥ 11.0 g/dL in females)
- Serum creatinine ≤1.5x ULN
- ALT and/or AST ≤ 1.5x ULN
- Total bilirubin ≤ 1.5x ULN
- Females of childbearing potential must commit to use one of the following highly effective methods of birth control consistently for at least 1 month prior to screening through study completion:
- Stable hormonal contraception with inhibition of ovulation; or
- Intrauterine device (IUD); or
- Bilateral tubal occlusion; or
- Surgical sterilization (vasectomy) of male partner at least 6 months prior to study; or
- Sexual abstinence (inactivity).
- To be considered of non-childbearing potential, females should be surgically sterilized (bilateral tubal ligation, hysterectomy, or bilateral oophorectomy at least 2 months prior to study) or be post-menopausal and at least 1 year since menses with follicle-stimulating hormone ≥ 40 units.
- Males should use condoms for contraception and refrain from donating sperm through Day 64.
- BMI between 18.5 and 33.5 inclusive
- Complies with current Pharmaron Covid-19 policies and procedures
Who cannot join
- Significant medical condition or laboratory abnormalities that in the opinion of the Principal Investigator preclude participation in the study.
- History of Covid symptoms or positive Covid test within 2 weeks prior to admission date.
- Alcohol or illicit drug abuse/dependency
- Positive serology results for HIV, HBsAg, or HCV with confirmatory assays.
- Pregnancy or breastfeeding
- Personal or documented family history of Guillain-Barr syndrome or neuromuscular disease; or an inflammatory arthritis such as reactive arthritis, ankylosing spondylitis, or rheumatoid arthritis; inflammatory bowel disease; autoimmune disease; malignancy (not including basal cell carcinoma); any immunocompromising condition; or history of major gastrointestinal surgery.
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- Evidence of neurological abnormalities.
- History of reactive arthritis or evidence of inflammatory arthritis on exam.
- Fever within the 2 weeks prior to time of enrollment.
- Evidence of IgA deficiency (serum IgA < 7 mg/mL or below the limit of detection of assay).
- HLA-B27 positive
- Allergy or prior intolerance to two or more of the following antibiotics: azithromycin, ciprofloxacin, levofloxacin, erythromycin, ampicillin, or amoxicillin/clavulanate.
- Allergy or prior intolerance to spirulina or spirulina products.
- Fewer than 3 stools per week or more than 3 stools per day as the usual frequency.
- History of moderate to serious diarrhea while traveling in a developing country within the last 3 years.
- History of myocarditis or pericarditis.
- History of major abdominal surgery or unexplained abdominal scar. Ok if appendectomy or cholecystectomy (one year post)
- Regular use of antidiarrheal, antacids, loperamide, bismuth subsalicylate diphenoxylate, or similar medication affecting bowel motility (regular defined as at least weekly).
- Use of proton pump inhibitors, H2 blockers, or other antacids within 48 hours preceding initiation of LMN-101 or placebo.
- Use of antibiotics during the 7 days preceding initiation of LMN-101 or placebo.
- Use of spirulina, or spirulina containing products, other than the study drug in the 30 days preceding initiation of LMN-101 or placebo.
- Use of any investigational product within 30 days preceding initiation of LMN-101 or placebo or planned use during the active study period.
- Use of any medication known to affect the immune system (e.g., systemic corticosteroids, chemotherapy, monoclonal antibody biologic response modifiers) within 12 months preceding initiation of LMN-101 or placebo or planned use during the active study period (excluding inhaled steroids with spacer).
- History of prior exposure to Campylobacter including by vaccination or infection in previous trials, or serum immunoglobulin A (IgA) titer to C. jejuni glycine extract >1:4000.
- Other dietary or environmental exposures that may place the subject at high risk for prior Campylobacter exposure (to be determined on a case-by-case basis by the PI).
- Employment as a food handler; childcare worker; or caregiver for elderly, immunocompromised individuals, or other at-risk population.
- History of major mental illness such as schizophrenia, major depression or suicidal ideation
- Any other criteria which, in the Principal Investigator's opinion, would compromise the ability of the subject to participate in the study, the safety of the study or the results of the study.
- Potential participant's 12 - lead electrocardiogram demonstrating pathologic abnormalities including non-sinus rhythm, pathologic Q waves, significant ST-T wave changes, corrected QT interval (QTc) using Fridericia correction (QTcF) at screening and Day -1 (admission) >450 msec.
- At screening, systolic blood pressure >140 mm Hg or diastolic blood pressure >90 mm Hg.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Single Dose Regimen Study of LMN-101 in Healthy Volunteers Challenged With Campylobacter Jejuni
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
- Being tested
- LMN-101, Placebo
- Medical subject headings
- Campylobacter Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LMN-101Biological
Also called Variable heavy chain (VHH) binding protein against flagellin
VHH-derived binding protein designed to bind and inhibit FlaA, flagellin filament protein of Campylobacter jejuni, delivered in whole spray-dried, spirulina biomass
PlaceboDrug
Also called Corn starch
Identical appearing placebo
| Study group | Role | What they receive |
|---|---|---|
| 3000-mg cohort | Active comparator | LMN-101, six 500-mg capsules orally three times daily for 14 days (n=21) Receives: Biological: LMN-101 |
| Placebo cohort | Placebo comparator | Placebo, six 500-mg capsules orally three times daily for 14 days (n=21) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Solicited or Unsolicited Adverse Events
Number of participants with solicited or unsolicited adverse events that received LMN-101 compared to placebo for the protocol-specified duration of collection for each type of adverse event.
Measured: Day 1 to Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2019
- Study start21 Feb 2022
- Primary completion4 Oct 2022
- Study completion4 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Campylobacter InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Healthy adults are treated with LMN-101 or placebo followed by an oral challenge of campylobacter to compare the frequency of solicited and unsolicited adverse events in subjects that received LMN-101 compared to placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lumen Bioscience, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Naval Medical Research Center, Pharmaron, University of Maryland
- Responsible party
- Sponsor
- Investigators
- Mohamed Al-Ibrahim, MB,ChB, FACP, Principal investigator, Pharmaron
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04182490
- Sponsor's protocol ID
- CAM02
- Status last verified
- Sep 2025
- First submitted
- 19 Sep 2019
- Last updated
- 25 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Single Dose Regimen Study of LMN-101 in Healthy Volunteers Challenged With Campylobacter Jejuni
- ClinicalTrials.gov ID
- NCT04182490
- Acronym / sponsor ID
- CAM02
- Conditions
- Campylobacter Infections
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Lumen Bioscience, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Naval Medical Research Center, Pharmaron, University of Maryland
- Study start
- 21 Feb 2022 (actual)
- Primary completion
- 4 Oct 2022 (actual)
- Study completion
- 4 Oct 2022 (actual)
- First posted
- 2 Dec 2019 (actual)
- Results
- Posted 25 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Healthy adults are treated with LMN-101 or placebo followed by an oral challenge of campylobacter to compare the frequency of solicited and unsolicited adverse events in subjects that received LMN-101 compared to placebo.
| Arm | Type | Receives |
|---|---|---|
| 3000-mg cohort | Active comparator | Biological: LMN-101LMN-101, six 500-mg capsules orally three times daily for 14 days (n=21) |
| Placebo cohort | Placebo comparator | Drug: PlaceboPlacebo, six 500-mg capsules orally three times daily for 14 days (n=21) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (24 listed)
- Male or non-pregnant female between 18 and 50 years of age, inclusive, at time of informed consent
- Willingness to participate after written informed consent obtained
- Available for all planned clinical visits (for physical examinations, blood draws, and stool collections) and follow-up monitoring (9 or 10 clinic visits and 1 phone interview 6 months post-challenge)
- Agreement to follow the restrictions of the study. Willing and able to follow the study directions and procedures, including the rules and procedures of the clinical research unit.
- Demonstrated comprehension of the protocol procedures including knowledge of Campylobacter illness by passing a written examination (passing grade ≥ 70%).
Key exclusion criteria (30 listed)
- Significant medical condition or laboratory abnormalities that in the opinion of the Principal Investigator preclude participation in the study.
- History of Covid symptoms or positive Covid test within 2 weeks prior to admission date.
- Alcohol or illicit drug abuse/dependency
- Positive serology results for HIV, HBsAg, or HCV with confirmatory assays.
- Pregnancy or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LMN-101Also: Variable heavy chain (VHH) binding protein against flagellinVHH-derived binding protein designed to bind and inhibit FlaA, flagellin filament protein of Campylobacter jejuni, delivered in whole spray-dried, spirulina biomass | Biological | 3000-mg cohort |
| PlaceboAlso: Corn starchIdentical appearing placebo | Drug | Placebo cohort |
Primary outcome
Number of Participants With Solicited or Unsolicited Adverse Events
Time frame: Day 1 to Day 14
Number of participants with solicited or unsolicited adverse events that received LMN-101 compared to placebo for the protocol-specified duration of collection for each type of adverse event.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Campylobacter Infections
RecruitingObservational study
Mucosal and Microbiota Changes During Acute Campylobacteriosis
Irritable Bowel Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed Al-Ibrahim, MB,ChB, FACP principal investigator
Pharmaron
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LMN-101 in people with Campylobacter Infections, run by Lumen Bioscience, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Solicited or Unsolicited Adverse Events (time frame: Day 1 to Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2025.