Study to Evaluate LPH-5 in Healthy Subjects

Lophora

Status and phase: Not yet enrolling; Phase 1

Conditions: Tolerance; Safety Issues

Treatments: Drug: LPH-5; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06722820

LPH-5CS01

Details and patient eligibility

About

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

Enrollment: 48 estimated patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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48 participants in 6 patient groups

Cohort 1

Experimental group

Description:

LPH-5_dose 1, single dose

Treatment:

Drug: Placebo

Drug: LPH-5

Cohort 2

Experimental group

Description:

LPH-5_dose 2, single dose

Treatment:

Drug: Placebo

Drug: LPH-5

Cohort 3

Experimental group

Description:

LPH-5_dose 3, single dose

Treatment:

Drug: Placebo

Drug: LPH-5

Cohort 4

Experimental group

Description:

LPH-5_dose 4, single dose

Treatment:

Drug: Placebo

Drug: LPH-5

Cohort 5

Experimental group

Description:

LPH-5_dose 5, single dose

Treatment:

Drug: Placebo

Drug: LPH-5

Cohort 6

Experimental group

Description:

LPH-5_dose 6, single dose

Treatment:

Drug: Placebo

Drug: LPH-5