Clinical trial NCT06722820: Study to Evaluate LPH-5 in Healthy Subjects
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Safety Issues
Tolerance
Lead sponsor: Lophora
Sponsor class: INDUSTRY
Collaborators: name: Biotrial
First posted: 2024-12-09
Enrollment: 48
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Incidence and severity of adverse events (AEs)
timeFrame: Through study completion, an average of 1 year
measure: Incidence of laboratory abnormalities, based on hematology, clinical chemistry, and urinalysis test results
timeFrame: Through study completion, an average of 1 year
measure: 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
Secondary outcomes:
measure: Pharmacokinetics parameters - Cmax
timeFrame: Time Frame: 0-48 hours
measure: Pharmacokinetics parameters - tmax
timeFrame: Time Frame: 0-48 hours
measure: Pharmacokinetics parameters - AUC0-t
timeFrame: Time Frame: 0-48 hours
measure: Pharmacokinetics parameters - AUC0-∞
timeFrame: Time Frame: 0-48 hours
measure: Pharmacokinetics parameters - AUC0-24h
timeFrame: Time Frame: 0-48 hours
measure: Pharmacokinetics parameters - AUC0-48h
timeFrame: Time Frame: 0-48 hours
measure: Pharmacokinetics parameters - half life
timeFrame: Time Frame: 0-48 hours
measure: Pharmacodynamic parameter - assessing the mood and subjective effects of single ascending doses of LPH-5 in healthy participants in questionnaires
timeFrame: Time Frame: 0-48 hours
measure: Pharmacodynamic parameter - Pharmaco-EEG (qEEG)
timeFrame: Time Frame: 0-48 hours
Other outcomes:
Locations:
Study officials:
affiliation: Biotrial
name: Sophie Hays, MD
role: PRINCIPAL_INVESTIGATOR
References: