Clinical TrialHealthy VolunteersPlaceboCompleted

A study on the safety, tolerability, and effects of GM-2505

This adaptive, randomised, double-blind, placebo-controlled trial (n=48) evaluated the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of single ascending intravenous doses of GM-2505 (second-gen, shorter duration, 5-HT2A agonist) in healthy volunteers.

Target Enrollment
48 participants
Study Type
Phase NA interventional
Design
Randomized, double Blind

Detailed Description

Adaptive single-ascending-dose, randomized, double-blind, placebo-controlled study in healthy volunteers assessing safety and tolerability of IV GM-2505 with cohorts receiving escalating single doses.

Primary outcomes include adverse events, labs, ECGs, vitals and psychometric measures up to 24 hours post-dose; secondary outcomes include detailed PK (AUC, Cmax, t1/2) and PD batteries (NeuroCart, VAS, MEQ-30, pharmaco-EEG).

Study Protocol

Preparation

sessions

Dosing

1 sessions
1440 min each

Integration

sessions

Study Arms & Interventions

GM-2505

experimental

Single-ascending-dose IV cohorts of investigational GM-2505 in healthy volunteers.

Interventions

  • Compound
    via IV• single dose

    GM-2505 (single-ascending IV doses across cohorts); exact mg per cohort not specified in registry fragment.

Placebo

inactive

Matched IV placebo control.

Interventions

  • Placebo
    via IV• single dose

    Matched IV placebo.

Participants

Ages
18 – 55
Sexes
Male & Female

Inclusion Criteria

  • 1. Healthy female or male subjects, aged 18 to 55 years old, inclusive. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical, surgical a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, and urinalysis. If the results of the serum chemistry panel, hematology, or urinalysis are outside the normal reference ranges, the subject may be included only if the investigator judges the abnormalities to be not clinically significant.
  • 2. Subject has a body mass index (BMI) between 18.0 and 30.0 kg/m2 inclusive (BMI=weight/height2) at screening.
  • 3. Self-report of at least one prior hallucinogen drug experience that included a meaningful altered state of consciousness in the past 5 years (psilocybin, LSD, DMT, ayahuasca, mescaline, ibogaine, 2C-drugs and/or ketamine).
  • 4. Subjects must be willing to adhere to the prohibitions and restrictions specified in the protocol, including attending all study visits, preparatory and follow-up sessions, and completing all study evaluations.
  • 5. Each subject must sign an informed consent form (ICF) and agree to refrain from using any psychoactive drugs from 30 days before first dosing and until the last follow-up visit and to refrain from using alcoholic beverages within 48 hours prior to admission of each treatment period.

Exclusion Criteria

  • 1. Clinically significant current or previous liver or renal insufficiency, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, metabolic or inflammatory illness, or any other illness that would compromise the well-being of the subject or the study or prevent the subject from meeting or performing study requirements according to the investigator.
  • 3. Subject has a history of or current hypertension (resting systolic blood pressure > 130 mmHg or diastolic blood pressure >90 mmHg) at screening.
  • 5. Resting heart rate (HR) greater than 100 or less than 45 beats per minute (bpm) at screening.
  • 7. Clinically significant personal or familial history of epilepsy, seizures, convulsions, or other seizure disorder (excluding febrile seizures as a child), previous head trauma or other risk factor for seizure.
  • 8. Clinically significant current or previous psychiatric disorder according to DSM 5. Specifically, current or previous psychotic disorders and bipolar disorder will be excluded.
  • 9. Family history of a psychotic disorder (whether in the context of bipolar disorder, schizophrenia or schizoaffective disorder) in first-degree and second-degree relatives.
  • 10. Clinically significant current or previous suicidality based on the C-SSRS and psychiatric history indicating current suicidal ideation or a history of active suicidal ideation or suicide attempts.
  • 11. Subject has a current or history of drug or alcohol use disorder according to DSM-IV and/or DSM 5 within the past 12 months.
  • 12. Use of psychoactive substances (including ketamine, esketamine, MDMA, cannabinoids) during the 6 weeks prior to screening. Single/occasional use may be allowed at the discretion of investigator.
  • 13. Ingestion of psychedelics (including psilocybin, DMT/ayahuasca, LSD, another serotonergic psychedelic) during 4 weeks prior to screening.
  • 14. Persistent psychological effects following the previous use of psilocybin, LSD, DMT, ayahuasca, mescaline, ibogaine, 2C-drugs and/or ketamine.
  • 15. Subject has a positive test result(s) for alcohol and/or drugs of abuse at screening or admission to the clinical unit.

Study Details

  • Status
    Completed
  • Phase
    Phase NA
  • Type
    interventional
  • Design
    Randomizeddouble Blind
  • Target Enrollment48 participants
  • Timeline
    Start: 2022-08-30
    End: 2023-07-01
  • Compound
    Placebo
  • Topic
    Healthy Volunteers

Locations

Centre for Human Drug Research — Leiden, Netherlands

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