Status:
COMPLETED
Safety and Pharmacokinetic Study of LMN-101 in Healthy Volunteers
Lead Sponsor:
Lumen Bioscience, Inc.
Conditions:
Campylobacter Jejuni Infection
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
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...
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 dos...
Eligibility Criteria
Inclusion
- 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
- 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.
Exclusion
- 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
- Alcohol or illicit drug abuse/dependency or positive urine toxicology screen for drugs of abuse other than marijuana. Alcohol and tobacco consumption are permitted.
Key Trial Info
Start Date :
November 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 24 2020
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT04098263
Start Date
November 15 2019
End Date
June 24 2020
Last Update
February 4 2025
Active Locations (1)
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1
Royal Brisbane & Women's Hospital
Herston, Queensland, Australia, 4029