Safety and Pharmacokinetic Study of LMN-101 in Healthy Volunteers (NCT04098263) | Clinical Trial Compass
CompletedPhase 1
Safety and Pharmacokinetic Study of LMN-101 in Healthy Volunteers
Australia21 participantsStarted 2019-11-15
Plain-language 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.
Who can participate
Age range18 Years – 50 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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).