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 range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.