Safety and Pharmacokinetic Study of LMN-101 in Healthy Volunteers

NCT04098263 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: CAM01
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Campylobacter Jejuni Infection

Outcome Measures

Primary Outcomes (1)

• Count of Participants With Adverse Events

  Counts of participants with adverse events

  Day 1 to Day 56

Study Arms (4)

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

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

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

Biological: LMN-101

Part A

OTHER

3000 mg PO single dose given as six 500-mg capsules of LMN-101 orally

Biological: LMN-101

Interventions

LMN-101 BIOLOGICAL

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; Part B: Cohort 1; Part B: Cohort 2; Part B: Cohort 3

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Lumen Bioscience, Inc.: lead

Study Sites (1)

Royal Brisbane & Women's Hospital

Herston, Queensland, 4029, Australia

Location

Results Point of Contact

• Title: Senior Medical Director
• Organization: Lumen Bioscience

trials@lumen.bio

206-899-1904

Study Officials

• Paul Griffin, MBBS

  Nucleus Network

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Part B: Identical-appearing placebo
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part A: Open Label Part B: Randomized, Double-Blind, Placebo-Controlled

Study Record Dates

• First Submitted: September 19, 2019
• First Posted: September 23, 2019
• Study Start: November 15, 2019
• Primary Completion: April 15, 2020
• Study Completion: June 24, 2020
• Last Updated: February 4, 2025
• Results First Posted: December 4, 2024

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)