IM and IV SPL026 Drug Product in Healthy Participants

NCT05644093 | Completed Phase 1

• 1 other identifier: CT026_003
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to test SPL026 given via injection into a muscle in healthy volunteers.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (8)

• Lab biochemistry [Safety & Tolerability]

  Values of potential clinical importance

  Change from baseline at Day 1 post dose

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  Adverse Events (AEs)

  Throughout the study until 14 days after dosing (Day 15 EOS)

• Heart Rate [Vital Signs - Safety & Tolerability]

  pulse rate will be measured in bpm

  Change from baseline heart rate at Day 1 or Day 2 post dose

• Blood Pressure [Vital Signs - Safety & Tolerability]

  arterial blood pressure

  Change from baseline blood pressure at Day 1 or Day 2 post dose

• Temperature [Vital Signs - Safety & Tolerability]

  tympanic temperature

  Change from baseline temperature at Day 1 or Day 2 post dose

• 12-lead ECG [Safety & Tolerability]

  QTcX intervals

  Change from baseline ECG at Day 1 or Day 2 post dose

• Physical Exam [Safety & Tolerability]

  Full physical exam screening and a brief symptom guided exam at Day -1 and Day 1

  Change from baseline at Day 1 post dose

• Beck Scale for Suicidal Ideation (BSS) - [Safety & Tolerability]

  The Beck Suicidal Ideation scale to monitor suicidal ideation

  Change from baseline at Day 15 post dose

Secondary Outcomes (3)

• Evaluation of plasma levels of DMT

  Day 1

• Mystical Experience Questionnaire (MEQ) - [Pharmacodynamics - Psychometric Scales and Questionnaires]

  Day 1 (dosing day)

• Challenging Experience Questionnaire (CEQ) - [Pharmacodynamics - Psychometric Scales and Questionnaires]

  Day 1 (dosing day)

Study Arms (2)

Psychedelic Experienced IM then IV crossover

EXPERIMENTAL

Participants will be dosed with IM SPL026 then IV SPL026 2-3 weeks later.

Drug: SPL026 IV; Drug: SPL026 IM

Psychedelic Naive IM dosing only

EXPERIMENTAL

Participants will be dosed with IM SPL026 one time.

Drug: SPL026 IM

Interventions

SPL026 IV DRUG

IV dosing

Also known as: DMT

Psychedelic Experienced IM then IV crossover

SPL026 IM DRUG

IM dosing

Also known as: DMT

Psychedelic Experienced IM then IV crossover; Psychedelic Naive IM dosing only

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Part A only
• Healthy psychedelic-experienced female or male participants (psychedelic-experienced is defined as having at least 2 previous experiences, with breakthrough, of serotonergic psychedelic drugs, including but not limited to: DMT, ayahausca, LSD, LSA \[morning glory seeds\], DOI \[2,5-Dimethoxy-4- iodoamphetamine\], DOB \[dimethoxybromoamphetamine\], DOC \[2,5- Dimethoxy-4-chloroamphetamine\], 2CB \[2-(4-bromo-2,5- dimethoxyphenyl)ethanamine\], 2CE \[1-(2,5-Dimethoxy-4-ethylphenyl)-2- aminoethane\], mescaline, peyote, san pedro, ibogaine and psilocybin \[including mushroom species containing psilocybin\]).
• No psychedelic drug use within 6 weeks prior to dosing.
• Part B only
• Healthy female or male participants with little to no psychedelic experience (defined as having never taken serotonergic psychedelic drugs, or have only taken sub-breakthrough doses of serotonergic psychedelic drugs, in any form, \< 5 times, including but not limited to: DMT, ayahuasca, LSD, LSA, DOI, DOB, DOC, 2CB, 2CE, mescaline, peyote, san pedro, ibogaine and psilocybin \[including mushroom species containing psilocybin\]).
• No psychedelic drug use within 6 months prior to dosing.
• Parts A and B
• Aged 25-65 years.
• A body mass index (BMI; Quetelet index) in the range 18.0-33.9 kg/m2. Body Mass Index =
• Sufficient intelligence to understand the nature of the trial and any hazards of participating in it. Ability to communicate satisfactorily with the investigator and to participate in, and comply with the requirements of, the entire trial.
• Willingness to give written consent to participate after reading the information and consent form, and after having the opportunity to discuss the trial with the investigator or his delegate.
• Agree to follow the contraception requirements of the trial.
• Agree not to donate blood or blood products during the study and for up to 3 months after the (last) administration of the trial medication.
• Willing to refrain from psychedelic drug use (excluding the study drug) during the trial and until the follow up call.
• Willingness to give written consent to have data entered into The Overvolunteering Prevention System (TOPS).

You may not qualify if:

• Current or previously diagnosed mental health disorder as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria.
• First degree relative with schizophrenia spectrum or other psychotic disorders, or bipolar and related disorders.
• Disposition judged by the investigator (or delegate) to be incompatible with establishment of rapport with therapy team and/or safe exposure to DMT.
• Woman who is pregnant or lactating, or pre-menopausal woman who is sexually active and not using a reliable method of contraception (see section 11).
• Clinically relevant abnormal history, physical findings, ECG, or laboratory values at the pre-trial screening assessment that could interfere with the objectives of the trial or the safety of the participant.
• Presence of acute or chronic illness, condition or infection, or history of chronic illness or condition (including psychological and neurological \[eg seizure\] disorder) considered sufficient to invalidate the participant's participation in the trial or make it unnecessarily hazardous.
• Impaired endocrine, thyroid, hepatic, respiratory or renal function, diabetes mellitus, coronary heart disease or any of the following cardiovascular conditions: arrhythmia, a clinically significant screening ECG abnormality or family history of long QT syndrome or sudden death, artificial heart valve, current or any history of hypertension, or any other significant current or history of cardiovascular condition, that may affect safety in the opinion of the investigator.
• History of serious suicide attempts (ie those that require hospitalisation); as assessed by the BSS.
• Presence or history of severe adverse reaction to any drug or a history of sensitivity to serotonergic psychedelic drugs.
• Use of a prescription medicine (except oral contraceptives or any hormone therapy), certain herbal supplements (eg St John's Wort, to be reviewed by trial physician), or over-the-counter medicine, during the 28 days before the first dose of trial medication. Use of acetaminophen (paracetamol) and non-steroidal anti-inflammatory drugs (eg ibuprofen) are permitted up to 4 h before the first dose of trial medication.
• Receipt of an investigational product (including prescription medicines) as part of another clinical trial within the 3 months before (first) admission to this study; in the follow-up period of another clinical trial at the time of screening for this study.
• Presence or history of drug or alcohol abuse, or intake of more than 14 units of alcohol weekly.
• Daily cannabis use or cannabis dependence as defined by ICD10.
• Use of cannabis in the 24 h before each study visit.
• Evidence of drug abuse on urine testing (with the exception of cannabis).

Sponsors & Collaborators

• Small Pharma Ltd: lead

Study Sites (1)

Hammersmith Medicines Research

London, United Kingdom

Location

Related Links

• Location of Clinical Study Report Synopsis

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Adeep Puri, MD

  HMR

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2022
• First Posted: December 9, 2022
• Study Start: January 3, 2023
• Primary Completion: April 5, 2023
• Study Completion: April 5, 2023
• Last Updated: March 22, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)