Health TrialsbyHealthPanel

Study to Evaluate LPH-5 in Healthy Subjects

ConditionsSafety IssuesTolerance
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18-65
SponsorLophora

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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

Design model

Sequential

Treatments tested in this trial

  • LPH-5

    Drug

    LPH-5

  • Placebo

    Drug

    Placebo

Treatment groups

48 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Cohort 1Experimental treatment 2 interventions
Group B: Cohort 2Experimental treatment 2 interventions
Group C: Cohort 3Experimental treatment 2 interventions
Group D: Cohort 4Experimental treatment 2 interventions
Group E: Cohort 5Experimental treatment 2 interventions
Group F: Cohort 6Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Incidence and severity of adverse events (AEs)

Time frame
Through study completion, an average of 1 year
2

Incidence of laboratory abnormalities, based on hematology, clinical chemistry, and urinalysis test results

Time frame
Through study completion, an average of 1 year
3

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 outcomes

1

Pharmacokinetics parameters - Cmax

Plasma PK concentrations including but not limited to: maximum plasma concentration (Cmax) (ng/ml)

Time frame
Time Frame: 0-48 hours
2

Pharmacokinetics parameters - tmax

Plasma PK concentrations including but not limited to: time to reach Cmax (tmax) (minutes)

Time frame
Time Frame: 0-48 hours
3

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
Time Frame: 0-48 hours
4

Pharmacokinetics parameters - AUC0-∞

Plasma PK concentrations including but not limited to: AUC from zero to infinity (AUC0-∞)(ng/ml x hours)

Time frame
Time Frame: 0-48 hours

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Lophora

Lead sponsor

Biotrial

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: