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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04098263




Registration number
NCT04098263
Ethics application status
Date submitted
19/09/2019
Date registered
23/09/2019

Titles & IDs
Public title
Safety and Pharmacokinetic Study of LMN-101 in Healthy Volunteers
Scientific title
A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation, Safety and Pharmacokinetic Study of LMN-101 in Healthy Volunteers
Secondary ID [1] 0 0
CAM01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Campylobacter Jejuni Infection 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - LMN-101

Active comparator: Part B: Cohort 1 - 300 mg PO TID given as a single 300-mg capsule of LMN-101 orally three times daily for 28 days

Active comparator: Part B: Cohort 2 - 1000 mg PO TID given as two 500-mg capsules of LMN-101 orally three times daily for 28 days

Active comparator: Part B: Cohort 3 - 3000 mg PO TID given as six 500-mg capsules of LMN-101 orally three times daily for 28 days

Other: Part A - 3000 mg PO single dose given as six 500-mg capsules of LMN-101 orally


Treatment: Other: LMN-101
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
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Rates of adverse events in LMN-101 subjects compared to placebo subjects
Timepoint [1] 0 0
Day 1 to Day 56
Primary outcome [2] 0 0
Tolerability of LMN-101: proportion of subjects completing study drug compared to placebo
Timepoint [2] 0 0
Day 1 to Day 56
Secondary outcome [1] 0 0
Pharmacokinetics: Peak serum concentration in LMN -101 subjects
Timepoint [1] 0 0
Day 1 to Day 29
Secondary outcome [2] 0 0
Pharmacokinetics: area under the curve in serum
Timepoint [2] 0 0
Day 1 to Day 29
Secondary outcome [3] 0 0
Anti-Drug Antibodies
Timepoint [3] 0 0
Day 1 to Day 56

Eligibility
Key inclusion criteria
1. Male or female between 18 and 50 years, inclusive, at time of informed consent
2. Willingness to participate after written informed consent obtained
3. Available for all planned clinical visits for physical examinations, blood draws, stool collections
4. General good health, without significant medical illness or abnormal physical examination findings as determined by the PI.
5. Adequate bone marrow reserve, renal and liver function.

1. Absolute neutrophil count = 1.5 x 10e9/L
2. Lymphocyte count < 6.0 x 10e9/L
3. Platelet count = 150 x 10e9/L
4. Hemoglobin = 110 g/L
5. Estimated glomerular filtration rate = 40 mL/min/1.73 meter squared
6. Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) = 3x upper limit of normal (ULN)
7. Total bilirubin = 1.5x ULN
8. Serum albumin = 28 g/L
6. Females of childbearing potential should be using and committed to continue using one of the following acceptable birth control methods:

1. Sexual abstinence (inactivity) or exclusively same-sex partner for 1 month prior to screening through study completion; or
2. Intrauterine device (IUD) in place for at least 1 month prior to study through study completion; or
3. Stable hormonal contraception for at least 1 month prior to study through study completion; or
4. Surgical sterilization (vasectomy) of male partner at least 6 months prior to study.
7. 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.
8. Male participants must use condoms during the study and through study completion.
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Treatment with an experimental compound within 30 days.
2. Treatment within 30 days or planned use within the study period with immunomodulator or immunosuppressant agent.
3. Pregnancy or breastfeeding.
4. Presence of any of the following clinical conditions:

1. 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).
2. History of venous thromboembolic disease within 12 months, myocardial infarction, or cerebrovascular accident.
3. Unstable pulmonary, renal, hepatic, endocrine or hematologic disease.
4. Gastrointestinal disorder requiring ongoing care by a physician.
5. Autoimmune disease, mixed connective tissue disease, scleroderma, polymyositis, or significant systemic involvement secondary to rheumatoid arthritis.
6. 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).
7. 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.
8. Positive serology for human immunodeficiency virus (HIV) infection or history of other immunodeficiency illness.
9. Positive serology results for hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV)
10. Significant neuromuscular disease or neuropathy
11. Psychiatric condition
12. Alcohol or illicit drug abuse/dependency or positive urine toxicology screen for drugs of abuse other than marijuana. Alcohol and tobacco consumption are permitted.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/11/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
24/06/2020
Sample size
Target
Accrual to date
Final
21
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Royal Brisbane & Women's Hospital - Herston
Recruitment postcode(s) [1] 0 0
4029 - Herston

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Lumen Bioscience, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Paul Griffin, MBBS
Address 0 0
Nucleus Network
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04098263