Campylobacter Jejuni InfectionPhase 1NCT04098263
Safety and Pharmacokinetic Study of LMN-101 in Healthy Volunteers
A Phase 1 study testing LMN-101 in people with Campylobacter Jejuni Infection, run by Lumen Bioscience, Inc. at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Campylobacter Jejuni Infection
- What is being tested?
- LMN-101
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteAustralia
- Study dates
- 15 Nov 2019to 24 Jun 2020
- Phase
- Phase 1
- 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 female between 18 and 50 years, 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, stool collections
- General good health, without significant medical illness or abnormal physical examination findings as determined by the PI.
- Adequate bone marrow reserve, renal and liver function.
- Absolute neutrophil count ≥ 1.5 x 10e9/L
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- Lymphocyte count < 6.0 x 10e9/L
- Platelet count ≥ 150 x 10e9/L
- Hemoglobin ≥ 110 g/L
- Estimated glomerular filtration rate ≥ 40 mL/min/1.73 meter squared
- Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≤ 3x upper limit of normal (ULN)
- Total bilirubin ≤ 1.5x ULN
- Serum albumin ≥ 28 g/L
- Females of childbearing potential should be using and committed to continue using one of the following acceptable birth control methods:
- Sexual abstinence (inactivity) or exclusively same-sex partner for 1 month prior to screening through study completion; or
- Intrauterine device (IUD) in place for at least 1 month prior to study through study completion; or
- Stable hormonal contraception for at least 1 month prior to study through study completion; or
- Surgical sterilization (vasectomy) of male partner at least 6 months prior to study.
- 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 3 years since last menses.
- Male participants must use condoms during the study and through study completion.
Who cannot join
- Treatment with an experimental compound within 30 days.
- Treatment within 30 days or planned use within the study period with immunomodulator or immunosuppressant agent.
- Pregnancy or breastfeeding.
- Presence of any of the following clinical conditions:
- History of one or more of the following: cardiac insufficiency (NYHA III/IV), uncontrolled cardiac arrhythmias, unstable ischemic heart disease, or uncontrolled hypertension (systolic blood pressure > 170 mmHg or diastolic blood pressure > 110 mmHg).
- History of venous thromboembolic disease within 12 months, myocardial infarction, or cerebrovascular accident.
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- Unstable pulmonary, renal, hepatic, endocrine or hematologic disease.
- Gastrointestinal disorder requiring ongoing care by a physician.
- Autoimmune disease, mixed connective tissue disease, scleroderma, polymyositis, or significant systemic involvement secondary to rheumatoid arthritis.
- Evidence of active malignant disease, malignancies diagnosed within the previous 5 years, or breast cancer diagnosed within the previous 5 years (except skin cancers other than melanoma).
- Known active current or history of recurrent bacterial, viral, fungal, mycobacterial or other opportunistic infections; or major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks.
- Positive serology for human immunodeficiency virus (HIV) infection or history of other immunodeficiency illness.
- Positive serology results for hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV)
- Significant neuromuscular disease or neuropathy
- Psychiatric condition
- Alcohol or illicit drug abuse/dependency or positive urine toxicology screen for drugs of abuse other than marijuana. Alcohol and tobacco consumption are permitted.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation, Safety and Pharmacokinetic Study of LMN-101 in Healthy Volunteers
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.
Read the detailed description
Healthy volunteers will be sequentially assigned to the following dosing regimens:
Part A:
A single, open-label dose of 3000 mg orally (2 subjects)
Part B:
Subjects will be randomized within a dose regimen to active or placebo treatment:
- 300 mg PO TID (three times daily) given as a single 300-mg capsule of LMN-101 orally three times daily for 28 days (4 subjects) or identical-appearing placebo capsule (2 subjects).
- 1000 mg PO TID given as two 500-mg capsules of LMN-101 orally three times daily for 28 days (4 subjects) or identical-appearing placebo capsules (2 subjects).
- 3000 mg PO TID given as six 500-mg capsules of LMN-101 orally three times daily for 28 days (4 subjects) or identical-appearing placebo capsules (2 subjects).
The primary endpoint is:
- Safety and tolerability of LMN-101.
The secondary endpoints are:
- Peak serum drug concentration following administration of the initial dose and peak serum drug concentration following a course of treatment (if systemic absorption is observed).
- Area under the serum drug concentration versus time curve (AUC) following administration of the initial dose and following a course of treatment (if systemic absorption is observed).
- Induction of serum anti-drug antibodies (if systemic absorption is observed).
- Conditions
- Campylobacter Jejuni Infection
- Being tested
- LMN-101
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Part B: Cohort 1 | Active comparator | 300 mg PO TID given as a single 300-mg capsule of LMN-101 orally three times daily for 28 days Receives: Biological: LMN-101 |
| Part B: Cohort 2 | Active comparator | 1000 mg PO TID given as two 500-mg capsules of LMN-101 orally three times daily for 28 days Receives: Biological: LMN-101 |
| Part B: Cohort 3 | Active comparator | 3000 mg PO TID given as six 500-mg capsules of LMN-101 orally three times daily for 28 days Receives: Biological: LMN-101 |
| Part A | Other | 3000 mg PO single dose given as six 500-mg capsules of LMN-101 orally Receives: Biological: LMN-101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Count of Participants With Adverse Events
Counts of participants with adverse events
Measured: Day 1 to Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2019
- Study start15 Nov 2019
- Primary completion15 Apr 2020
- Study completion24 Jun 2020
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 Jejuni InfectionStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Part A: Open Label Part B: Randomized, Double-Blind, Placebo-Controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lumen Bioscience, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul Griffin, MBBS, Principal investigator, Nucleus Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04098263
- Sponsor's protocol ID
- CAM01
- Status last verified
- Jan 2025
- First submitted
- 19 Sep 2019
- Last updated
- 4 Feb 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 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation, Safety and Pharmacokinetic Study of LMN-101 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04098263
- Acronym / sponsor ID
- CAM01
- Conditions
- Campylobacter Jejuni Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Lumen Bioscience, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Nov 2019 (actual)
- Primary completion
- 15 Apr 2020 (actual)
- Study completion
- 24 Jun 2020 (actual)
- First posted
- 23 Sep 2019 (actual)
- Results
- Posted 4 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Healthy volunteers will be sequentially assigned to the following dosing regimens:
Part A:
A single, open-label dose of 3000 mg orally (2 subjects)
Part B:
Subjects will be randomized within a dose regimen to active or placebo treatment:
- 300 mg PO TID (three times daily) given as a single 300-mg capsule of LMN-101 orally three times daily for 28 days (4 subjects) or identical-appearing placebo capsule (2 subjects).
- 1000 mg PO TID given as two 500-mg capsules of LMN-101 orally three times daily for 28 days (4 subjects) or identical-appearing placebo capsules (2 subjects).
- 3000 mg PO TID given as six 500-mg capsules of LMN-101 orally three times daily for 28 days (4 subjects) or identical-appearing placebo capsules (2 subjects).
The primary endpoint is:
- Safety and tolerability of LMN-101.
The secondary endpoints are:
- Peak serum drug concentration following administration of the initial dose and peak serum drug concentration following a course of treatment (if systemic absorption is observed).
- Area under the serum drug concentration versus time curve (AUC) following administration of the initial dose and following a course of treatment (if systemic absorption is observed).
- Induction of serum anti-drug antibodies (if systemic absorption is observed).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Part A: Open Label Part B: Randomized, Double-Blind, Placebo-Controlled
| Arm | Type | Receives |
|---|---|---|
| Part B: Cohort 1 | Active comparator | Biological: LMN-101300 mg PO TID given as a single 300-mg capsule of LMN-101 orally three times daily for 28 days |
| Part B: Cohort 2 | Active comparator | Biological: LMN-1011000 mg PO TID given as two 500-mg capsules of LMN-101 orally three times daily for 28 days |
| Part B: Cohort 3 | Active comparator | Biological: LMN-1013000 mg PO TID given as six 500-mg capsules of LMN-101 orally three times daily for 28 days |
| Part A | Other | Biological: LMN-1013000 mg PO single dose given as six 500-mg capsules of LMN-101 orally |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (20 listed)
- Male or female between 18 and 50 years, 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, stool collections
- General good health, without significant medical illness or abnormal physical examination findings as determined by the PI.
- Adequate bone marrow reserve, renal and liver function.
Key exclusion criteria (16 listed)
- Treatment with an experimental compound within 30 days.
- Treatment within 30 days or planned use within the study period with immunomodulator or immunosuppressant agent.
- Pregnancy or breastfeeding.
- Presence of any of the following clinical conditions:
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-101variable heavy chain-derived binding protein designed to bind and inhibit flagellin filament protein of Campylobacter jejuni, delivered in whole spray-dried, encapsulated spirulina biomass | Biological | Part A, Part B: Cohort 1, Part B: Cohort 2, Part B: Cohort 3 |
Primary outcome
Count of Participants With Adverse Events
Time frame: Day 1 to Day 56
Counts of participants with adverse events
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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.
Paul Griffin, MBBS principal investigator
Nucleus Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LMN-101 in people with Campylobacter Jejuni Infection, run by Lumen Bioscience, Inc. at 1 site in Australia.
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 20 inclusion and 16 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 4 Feb 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 Australia. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 4 Dec 2024). 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?
Count of Participants With Adverse Events (time frame: Day 1 to Day 56). 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 4 Feb 2025.