Study to Evaluate LPH-5 in Healthy Subjects

Phase 1

Not yet recruiting

• Conditions: Safety Issues; Tolerance
• Interventions: Drug: LPH-5; Drug: Placebo

• Registration Number: NCT06722820
• Lead Sponsor: Lophora

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-19
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-03
• Last Update Submitted: 2024-12-03
• Study First Posted: 2024-12-09
• Last Update Posted: 2024-12-09
• Study Start: 2025-04-30
• Primary Completion: 2025-11-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Cohort 4	LPH-5	LPH-5_dose 4, single dose
Cohort 5	LPH-5	LPH-5_dose 5, single dose
Cohort 6	LPH-5	LPH-5_dose 6, single dose
Cohort 1	LPH-5	LPH-5_dose 1, single dose
Cohort 1	Placebo	LPH-5_dose 1, single dose
Cohort 2	LPH-5	LPH-5_dose 2, single dose
Cohort 2	Placebo	LPH-5_dose 2, single dose
Cohort 3	LPH-5	LPH-5_dose 3, single dose
Cohort 3	Placebo	LPH-5_dose 3, single dose
Cohort 4	Placebo	LPH-5_dose 4, single dose
Cohort 5	Placebo	LPH-5_dose 5, single dose
Cohort 6	Placebo	LPH-5_dose 6, single dose

Primary Outcome Measures

Name	Time	Method
Incidence and severity of adverse events (AEs)	Through study completion, an average of 1 year
Incidence of laboratory abnormalities, based on hematology, clinical chemistry, and urinalysis test results	Through study completion, an average of 1 year
Incidence of abnormal clinical laboratory findings in 12-lead ECG parameters, vital signs, and physical examination	Through study completion, an average of 1 year

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics parameters - AUC0-t	Time Frame: 0-48 hours	Plasma PK concentrations including but not limited to: area under the plasma concentration-time curve (AUC) from zero to the last quantifiable concentration (AUC0-t) (ng/ml x hours)
Pharmacokinetics parameters - AUC0-∞	Time Frame: 0-48 hours	Plasma PK concentrations including but not limited to: AUC from zero to infinity (AUC0-∞)(ng/ml x hours)
Pharmacokinetics parameters - AUC0-24h	Time Frame: 0-48 hours	Plasma PK concentrations including but not limited to: AUC from zero to 24 hours (AUC0-24h) (ng/ml x hours)
Pharmacokinetics parameters - half life	Time Frame: 0-48 hours	Plasma PK concentrations including but not limited to: half life (t1/2) (hours)
Pharmacokinetics parameters - Cmax	Time Frame: 0-48 hours	Plasma PK concentrations including but not limited to: maximum plasma concentration (Cmax) (ng/ml)
Pharmacokinetics parameters - tmax	Time Frame: 0-48 hours	Plasma PK concentrations including but not limited to: time to reach Cmax (tmax) (minutes)
Pharmacokinetics parameters - AUC0-48h	Time Frame: 0-48 hours	Plasma PK concentrations including but not limited to: AUC from zero to 48 hours (AUC0-48h) (ng/ml x hours)
Pharmacodynamic parameter - assessing the mood and subjective effects of single ascending doses of LPH-5 in healthy participants in questionnaires	Time Frame: 0-48 hours
Pharmacodynamic parameter - Pharmaco-EEG (qEEG)	Time Frame: 0-48 hours	Power spectral analysis of absolute and/or relative amplitude in the various frequency bands.