Study to Evaluate LPH-5 in Healthy Subjects
This Phase I, randomised, double-blind, placebo-controlled sequential trial (n=48) studied single ascending doses of LPH-5 in healthy male participants aged 18 to 65 years. Six cohorts received one of six dose levels of LPH-5 or placebo, with the main aim of assessing safety and tolerability. The trial also evaluated LPH-5 pharmacokinetics over 48 hours and pharmacodynamic effects using subjective mood questionnaires and quantitative EEG. LPH-5 is represented in Blossom under the 2C-X compound family because 2C-B is the closest psychedelic in the current taxonomy.
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Detailed Description
This study will explore the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of LPH-5.
Study Arms & Interventions
LPH-5 Cohort 1
experimentalLPH-5_dose 1, single dose
Interventions
- 2C-X• single dose• 1 doses total
LPH-5; represented under Blossom’s 2C-X record because 2C-B is the closest psychedelic.
- Placebo• single dose• 1 doses total
LPH-5 Cohort 2
experimentalLPH-5_dose 2, single dose
Interventions
- 2C-X• single dose• 1 doses total
LPH-5; represented under Blossom’s 2C-X record because 2C-B is the closest psychedelic.
- Placebo• single dose• 1 doses total
LPH-5 Cohort 3
experimentalLPH-5_dose 3, single dose
Interventions
- 2C-X• single dose• 1 doses total
LPH-5; represented under Blossom’s 2C-X record because 2C-B is the closest psychedelic.
- Placebo• single dose• 1 doses total
LPH-5 Cohort 4
experimentalLPH-5_dose 4, single dose
Interventions
- 2C-X• single dose• 1 doses total
LPH-5; represented under Blossom’s 2C-X record because 2C-B is the closest psychedelic.
- Placebo• single dose• 1 doses total
LPH-5 Cohort 5
experimentalLPH-5_dose 5, single dose
Interventions
- 2C-X• single dose• 1 doses total
LPH-5; represented under Blossom’s 2C-X record because 2C-B is the closest psychedelic.
- Placebo• single dose• 1 doses total
LPH-5 Cohort 6
experimentalLPH-5_dose 6, single dose
Interventions
- 2C-X• single dose• 1 doses total
LPH-5; represented under Blossom’s 2C-X record because 2C-B is the closest psychedelic.
- Placebo• single dose• 1 doses total
Participants
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 Protocol, Arms & Participants
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Recent activity
- CompletedStudy to Evaluate LPH-5 in Healthy Subjects (NCT06722820, 2c-x)
- StartedStudy to Evaluate LPH-5 in Healthy Subjects (NCT06722820, 2c-x)
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