Dose-finding PKPD Trial for RE02 in Healthy... — Clinical Trial Details

Randomized, triple-masked crossover in healthy volunteers comparing three RE02 dose levels with a mannitol placebo across four single-dose study days, with a 6-hour intensive PK/PD assessment on each day.

Primary aims are dose–exposure characterisation and safety/tolerability; intervention embedded in a controlled setting with continuous psychological support and close adverse-event monitoring.

Participants

Ages

25 – 45

Sexes

Male & Female

BMI

Psychosis History

Excluded

Inclusion Criteria

Inclusion Criteria:
Willing and capable to give informed consent for the participation in the study after it has been thoroughly explained
Willing to refrain from drinking alcohol one day before testing days and caffeinated drinks at the testing days and from consuming psychoactive substances or other medications for 2 weeks before testing days and for the duration of the study
Already experienced with psychedelic substances (at least 5 prior experiences - microdoses do not count)
Able and willing to comply with all study requirements
Informed consent form was signed
Good knowledge of the German language
Participant informs study physicians / project scientists about simultaneous treatment or therapy with other physicians and about current intake of psychotropic substances or medication
Women of childbearing potential are required to use effective, established contraception, such as oral, injected or implanted hormonal methods of contraception, placement of an intrauterine device (IUD) or intrauterine system (IUS), barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository

Exclusion Criteria

Exclusion Criteria:
Previous significant adverse response to a hallucinogenic drug
Participation in another study where pharmaceutical compounds will be given
Presence of Axis I affective, anxiety, or dissociative disorders
Present or antecedent diagnosis of bipolar disorder (I, II, not otherwise specified), schizophrenia, schizoaffective disorder, psychosis, or other disorders from the psychotic spectrum
First-degree relatives with present or antecedent schizophrenia, schizoaffective disorder, or bipolar disorder type I
History of head trauma, seizures, cancer, or cerebrovascular accidents
Recent cardiac or brain surgery
Current abuse of medication or psychotropic substances (including nicotine addiction) according to SCID I criteria
Presence of major internal or neurological disorders (including sepsis, pheochromocytoma, thyrotoxicosis, drug-induced fibrosis, familiar or basilar artery migraine)
Cardiovascular disease (hypertonia, coronary artery disease, heart insufficiency, myocardical infarction, coronary spastic angina)
Peripheral vascular disease (thromboangiitis obliterans, luetic arteritis, severe arteriosclerosis, thrombophlebitis, Raynaud's disease)
Cerebrovascular disease (e.g., stroke, intracranial bleeding / hemorrhage, intracranial aneurysm)
Serious abnormalities in ECG or blood count/chemistry
Liver or renal or pulmonary disease
Current use of medications with significant interaction potential with MAOI (e.g., antidepressants, antipsychotics, psychostimulants, dopaminergic/serotonergic agents, anticonvulsants)
high risk of adverse emotional or behavioral reaction based on investigator's clinical evaluation (e.g., evidence of serious personality disorder, serious current stressors, lack of social support)

Company

Product

Legal

Dose-finding PKPD Trial for RE02 in Healthy Subjects

Detailed Description

Study Protocol

Preparation

Dosing

Locations

Integration

Therapeutic Protocol

Study Arms & Interventions

Placebo

Interventions

Low dose RE02

Interventions

Moderate dose RE02

Interventions

High dose RE02

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details

Study Team

Sponsors & Collaborators