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NCT06722820 | NOT YET RECRUITING | Safety Issues

Study to Evaluate LPH-5 in Healthy Subjects
Sponsor:

Lophora

Brief Summary:

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

Condition or disease

Safety Issues

Tolerance

Intervention/treatment

LPH-5

Placebo

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 48 participants
Masking : DOUBLE
Primary Purpose : TREATMENT
Official Title : Phase I, First-in-man, Randomised, Placebo-controlled, Single Dose Escalation Study to Investigate the Effects of LPH-5 on Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Parameters in Healthy Participants
Actual Study Start Date : 2025-04-30
Estimated Primary Completion Date : 2025-11-30
Estimated Study Completion Date : 2025-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: MALE
Accepts Healthy Volunteers: 1
Criteria
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.
Study to Evaluate LPH-5 in Healthy Subjects

Location Details

NCT06722820

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

No Location Found