Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety and Pharmacokinetic Study of LMN-101 in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04098263
Recruitment Status : Active, not recruiting
First Posted : September 23, 2019
Last Update Posted : May 28, 2020
Sponsor:
Information provided by (Responsible Party):
Lumen Bioscience, Inc.

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Campylobacter Jejuni Infection Biological: LMN-101 Phase 1

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).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Part A: Open Label Part B: Randomized, Double-Blind, Placebo-Controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Part B: Identical-appearing placebo
Primary Purpose: Prevention
Official Title: A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation, Safety and Pharmacokinetic Study of LMN-101 in Healthy Volunteers
Actual Study Start Date : November 15, 2019
Actual Primary Completion Date : April 15, 2020
Estimated Study Completion Date : June 24, 2020

Arm Intervention/treatment
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
Biological: 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

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
Biological: 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

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
Biological: 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

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




Primary Outcome Measures :
  1. Rates of adverse events in LMN-101 subjects compared to placebo subjects [ Time Frame: Day 1 to Day 56 ]
    adverse events graded according to severity and rates compared between LMN-101 subjects and placebo subjects

  2. Tolerability of LMN-101: proportion of subjects completing study drug compared to placebo [ Time Frame: Day 1 to Day 56 ]
    proportion of subjects completing study drug and remaining on study and free from possibly drug-related and dose-limiting serious adverse events


Secondary Outcome Measures :
  1. Pharmacokinetics: Peak serum concentration in LMN -101 subjects [ Time Frame: Day 1 to Day 29 ]
    Peak serum drug concentration in subjects receiving LMN-101

  2. Pharmacokinetics: area under the curve in serum [ Time Frame: Day 1 to Day 29 ]
    Area under the serum drug concentration versus time curve in subjects receiving LMN-101 at each dose level

  3. Anti-Drug Antibodies [ Time Frame: Day 1 to Day 56 ]
    Induction of serum anti-drug IgG antibodies



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04098263


Locations
Layout table for location information
Australia, Queensland
Royal Brisbane & Women's Hospital
Herston, Queensland, Australia, 4029
Sponsors and Collaborators
Lumen Bioscience, Inc.
Layout table for additonal information
Responsible Party: Lumen Bioscience, Inc.
ClinicalTrials.gov Identifier: NCT04098263    
Other Study ID Numbers: CAM01
First Posted: September 23, 2019    Key Record Dates
Last Update Posted: May 28, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes