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Not yet recruiting NCT06722820

Study to Evaluate LPH-5 in Healthy Subjects

Phase I Interventional Safety Issues Tolerance

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: LPH-5, Placebo.
Who it may be relevant to
Registry conditions: Safety Issues, Tolerance. Basic parameters: 18 years — 65 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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

Interventions

  • Drug LPH-5
    LPH-5
  • Drug Placebo
    Placebo

Primary outcome measures

  • Incidence and severity of adverse events (AEs) [Time frame: Through study completion, an average of 1 year]
  • Incidence of laboratory abnormalities, based on hematology, clinical chemistry, and urinalysis test results [Time frame: Through study completion, an average of 1 year]
  • Incidence of abnormal clinical laboratory findings in 12-lead ECG parameters, vital signs, and physical examination [Time frame: Through study completion, an average of 1 year]
Secondary outcome measures (9)
  • Pharmacokinetics parameters - Cmax [Time frame: Time Frame: 0-48 hours]
  • Pharmacokinetics parameters - tmax [Time frame: Time Frame: 0-48 hours]
  • Pharmacokinetics parameters - AUC0-t [Time frame: Time Frame: 0-48 hours]
  • Pharmacokinetics parameters - AUC0-∞ [Time frame: Time Frame: 0-48 hours]
  • Pharmacokinetics parameters - AUC0-24h [Time frame: Time Frame: 0-48 hours]
  • Pharmacokinetics parameters - AUC0-48h [Time frame: Time Frame: 0-48 hours]
  • Pharmacokinetics parameters - half life [Time frame: 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: Time Frame: 0-48 hours]
  • Pharmacodynamic parameter - Pharmaco-EEG (qEEG) [Time frame: Time Frame: 0-48 hours]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Sequential
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06722820 · LPH-5CS01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗