Study to Evaluate LPH-5 in Healthy Subjects

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Tolerance; Safety Issues
• Intervention / Treatment: Drug: Placebo; Drug: LPH-5

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Mikael Thomsen, PhD; Phone Number: 23276134; Email: mik.thomsen@gmail.com
• Study Contact Backup: Name: Jesper Kristensen, PhD; Phone Number: 25709521; Email: jk@lophora.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1; LPH-5_dose 1, single dose	Drug: Placebo; Placebo; Drug: LPH-5; LPH-5
Experimental: Cohort 2; LPH-5_dose 2, single dose	Drug: Placebo; Placebo; Drug: LPH-5; LPH-5
Experimental: Cohort 3; LPH-5_dose 3, single dose	Drug: Placebo; Placebo; Drug: LPH-5; LPH-5
Experimental: Cohort 4; LPH-5_dose 4, single dose	Drug: Placebo; Placebo; Drug: LPH-5; LPH-5
Experimental: Cohort 5; LPH-5_dose 5, single dose	Drug: Placebo; Placebo; Drug: LPH-5; LPH-5
Experimental: Cohort 6; LPH-5_dose 6, single dose	Drug: Placebo; Placebo; Drug: LPH-5; LPH-5

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics parameters - Cmax	Plasma PK concentrations including but not limited to: maximum plasma concentration (Cmax) (ng/ml)	Time Frame: 0-48 hours
Pharmacokinetics parameters - tmax	Plasma PK concentrations including but not limited to: time to reach Cmax (tmax) (minutes)	Time Frame: 0-48 hours
Pharmacokinetics parameters - AUC0-t	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)	Time Frame: 0-48 hours
Pharmacokinetics parameters - AUC0-∞	Plasma PK concentrations including but not limited to: AUC from zero to infinity (AUC0-∞)(ng/ml x hours)	Time Frame: 0-48 hours
Pharmacokinetics parameters - AUC0-24h	Plasma PK concentrations including but not limited to: AUC from zero to 24 hours (AUC0-24h) (ng/ml x hours)	Time Frame: 0-48 hours
Pharmacokinetics parameters - AUC0-48h	Plasma PK concentrations including but not limited to: AUC from zero to 48 hours (AUC0-48h) (ng/ml x hours)	Time Frame: 0-48 hours
Pharmacokinetics parameters - half life	Plasma PK concentrations including but not limited to: half life (t1/2) (hours)	Time Frame: 0-48 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)	Power spectral analysis of absolute and/or relative amplitude in the various frequency bands.	Time Frame: 0-48 hours

Collaborators and Investigators

• Sponsor: Lophora
• Collaborators: Biotrial
• Investigators: Principal Investigator: Sophie Hays, MD, Biotrial

Study record dates

Study Major Dates

• Study Start (Estimated): April 30, 2025
• Primary Completion (Estimated): November 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: November 19, 2024
• First Submitted That Met QC Criteria: December 3, 2024
• First Posted (Estimated): December 9, 2024

Study Record Updates

• Last Update Posted (Estimated): December 9, 2024
• Last Update Submitted That Met QC Criteria: December 3, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: LPH-5CS01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No