Not Yet RecruitingPhase 1

Study to Evaluate LPH-5 in Healthy Subjects

48 participantsStarted 2025-04-30

Plain-language summary

This study will explore the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of LPH-5.

Who can participate

Age range

18 Years – 65 Years

Sex

MALE

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: * Healthy as determined by a responsible physician, based on medical evaluation including medical history, physical examination, concomitant medication, vital signs, 12-lead ECG, and clinical laboratory evaluations. Exclusion Criteria: * Any condition or disease detected during the medical interview/physical examination that could relapse during or immediately after the study, or would render the participant unsuitable for the study, place the participant at undue risk, or interfere with the ability of the participant to complete the clinical study, as determined by the Investigator. * Have a history of and/or current clinically significant determined by the Investigator * Consumes cannabis or cannabis-derived compounds more than 3 times per month or has substantial changes in cannabis consumption in the 21 days prior to screening.

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.

What they're measuring

Incidence and severity of adverse events (AEs)

Timeframe: Through study completion, an average of 1 year

Incidence of laboratory abnormalities, based on hematology, clinical chemistry, and urinalysis test results

Timeframe: Through study completion, an average of 1 year

Incidence of abnormal clinical laboratory findings in 12-lead ECG parameters, vital signs, and physical examination

Timeframe: Through study completion, an average of 1 year

Trial details

NCT IDNCT06722820

SponsorLophora

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-11-30

Contact for this trial

Mikael Thomsen, PhD

23276134 mik.thomsen@gmail.com

View on ClinicalTrials.gov More Safety Issues trials

Who can participate

Age range

18 Years – 65 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Incidence and severity of adverse events (AEs)

Timeframe: Through study completion, an average of 1 year

Incidence of laboratory abnormalities, based on hematology, clinical chemistry, and urinalysis test results

Timeframe: Through study completion, an average of 1 year

Incidence of abnormal clinical laboratory findings in 12-lead ECG parameters, vital signs, and physical examination

Timeframe: Through study completion, an average of 1 year