Study to Evaluate LPH-5 in Healthy Subjects

NCT06722820 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: LPH-5CS01
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Safety Issues; Tolerance

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• Pharmacokinetics parameters - Cmax

  Time Frame: 0-48 hours

• Pharmacokinetics parameters - tmax

  Time Frame: 0-48 hours

• Pharmacokinetics parameters - AUC0-t

  Time Frame: 0-48 hours

• Pharmacokinetics parameters - AUC0-∞

  Time Frame: 0-48 hours

• Pharmacokinetics parameters - AUC0-24h

  Time Frame: 0-48 hours

Study Arms (6)

Cohort 1

EXPERIMENTAL

LPH-5\_dose 1, single dose

Drug: LPH-5; Drug: Placebo

Cohort 2

EXPERIMENTAL

LPH-5\_dose 2, single dose

Drug: LPH-5; Drug: Placebo

Cohort 3

EXPERIMENTAL

LPH-5\_dose 3, single dose

Drug: LPH-5; Drug: Placebo

Cohort 4

EXPERIMENTAL

LPH-5\_dose 4, single dose

Drug: LPH-5; Drug: Placebo

Cohort 5

EXPERIMENTAL

LPH-5\_dose 5, single dose

Drug: LPH-5; Drug: Placebo

Cohort 6

EXPERIMENTAL

LPH-5\_dose 6, single dose

Drug: LPH-5; Drug: Placebo

Interventions

LPH-5 DRUG

LPH-5

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5; Cohort 6

Placebo DRUG

Placebo

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5; Cohort 6

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lophora: lead
• Biotrial: collaborator

Study Officials

• Sophie Hays, MD

  Biotrial

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mikael Thomsen, PhD

CONTACT

23276134; mik.thomsen@gmail.com

Jesper Kristensen, PhD

CONTACT

25709521; jk@lophora.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: December 9, 2024
• Study Start: April 30, 2025
• Primary Completion: November 30, 2025
• Study Completion: December 31, 2025
• Last Updated: December 9, 2024

Record last verified: 2024-12