IM and IV SPL026 Drug Product in Healthy Participants

Last updated: March 20, 2024
Sponsor: Small Pharma Ltd
Overall Status: Completed

Phase

1

Condition

Depression (Major/severe)

Depression

Affective Disorders

Treatment

SPL026 IM

SPL026 IV

Clinical Study ID

NCT05644093
CT026_003
  • Ages 25-65
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria: Part A only 1. Healthy psychedelic-experienced female or male participants (psychedelic-experiencedis defined as having at least 2 previous experiences, with breakthrough, ofserotonergic 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 [includingmushroom species containing psilocybin]). 2. No psychedelic drug use within 6 weeks prior to dosing. Part B only 3. Healthy female or male participants with little to no psychedelic experience (definedas having never taken serotonergic psychedelic drugs, or have only takensub-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 speciescontaining psilocybin]). 4. No psychedelic drug use within 6 months prior to dosing. Parts A and B 5. Aged 25-65 years. 6. A body mass index (BMI; Quetelet index) in the range 18.0-33.9 kg/m2. Body Mass Index

  1. Sufficient intelligence to understand the nature of the trial and any hazards ofparticipating in it. Ability to communicate satisfactorily with the investigator andto participate in, and comply with the requirements of, the entire trial.
  2. Willingness to give written consent to participate after reading the information andconsent form, and after having the opportunity to discuss the trial with theinvestigator or his delegate.
  3. Agree to follow the contraception requirements of the trial.
  4. Agree not to donate blood or blood products during the study and for up to 3 monthsafter the (last) administration of the trial medication.
  5. Willing to refrain from psychedelic drug use (excluding the study drug) during thetrial and until the follow up call.
  6. Willingness to give written consent to have data entered into The OvervolunteeringPrevention System (TOPS).
  7. Willing to be contacted by email and video call, and have online access.
  8. Has veins deemed suitable for cannulation (IV infusion and/or blood sampling).

Exclusion

Exclusion Criteria:

  1. Current or previously diagnosed mental health disorder as defined by Diagnostic andStatistical Manual of Mental Disorders (DSM-V) criteria.
  2. First degree relative with schizophrenia spectrum or other psychotic disorders, orbipolar and related disorders.
  3. Disposition judged by the investigator (or delegate) to be incompatible withestablishment of rapport with therapy team and/or safe exposure to DMT.
  4. Woman who is pregnant or lactating, or pre-menopausal woman who is sexually active andnot using a reliable method of contraception (see section 11).
  5. Clinically relevant abnormal history, physical findings, ECG, or laboratory values atthe pre-trial screening assessment that could interfere with the objectives of thetrial or the safety of the participant.
  6. Presence of acute or chronic illness, condition or infection, or history of chronicillness or condition (including psychological and neurological [eg seizure] disorder)considered sufficient to invalidate the participant's participation in the trial ormake it unnecessarily hazardous.
  7. Impaired endocrine, thyroid, hepatic, respiratory or renal function, diabetesmellitus, coronary heart disease or any of the following cardiovascular conditions:arrhythmia, a clinically significant screening ECG abnormality or family history oflong QT syndrome or sudden death, artificial heart valve, current or any history ofhypertension, or any other significant current or history of cardiovascular condition,that may affect safety in the opinion of the investigator.
  8. History of serious suicide attempts (ie those that require hospitalisation); asassessed by the BSS.
  9. Presence or history of severe adverse reaction to any drug or a history of sensitivityto serotonergic psychedelic drugs.
  10. 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), orover-the-counter medicine, during the 28 days before the first dose of trialmedication. Use of acetaminophen (paracetamol) and non-steroidal anti-inflammatorydrugs (eg ibuprofen) are permitted up to 4 h before the first dose of trialmedication.
  11. Receipt of an investigational product (including prescription medicines) as part ofanother clinical trial within the 3 months before (first) admission to this study; inthe follow-up period of another clinical trial at the time of screening for thisstudy.
  12. Presence or history of drug or alcohol abuse, or intake of more than 14 units ofalcohol weekly.
  13. Daily cannabis use or cannabis dependence as defined by ICD10.
  14. Use of cannabis in the 24 h before each study visit.
  15. Evidence of drug abuse on urine testing (with the exception of cannabis).
  16. Unable to be nicotine free (refrain from smoking or nicotine-containing products) for 24 h before and until the morning after dosing.
  17. Blood pressure and pulse rate in the supine and standing position at the screeningexamination outside the ranges: blood pressure 80-150 mm Hg systolic; 30-100 mm Hgdiastolic; pulse rate 40-100 beats/min. Borderline values (ie values that are within 5mm Hg of the range for blood pressure or 5 beats/min of the range for pulse rate) willbe repeated. Participants can be included if the repeat value is within range or stillborderline but deemed not clinically significant by the investigator.
  18. QTcF value at screening greater than 450 msec (men) or 470 msec (women) on 12-leadECG. Triplicate measurements will be made, and a mean QTcF value higher than 450 msec (men) or 470 msec (women) will lead to exclusion. A repeat (in triplicate) is allowedon one occasion for determination of eligibility.
  19. Possibility that the participant will not cooperate with the requirements of theprotocol.
  20. Positive test for hepatitis B, hepatitis C or human immunodeficiency virus (HIV).
  21. Loss of more than 400 mL blood during the 3 months before the trial, eg as a blooddonor.
  22. Phobia of needles or blood.
  23. Objection by General Practitioner (GP) to participant entering trial.

Study Design

Total Participants: 14
Treatment Group(s): 2
Primary Treatment: SPL026 IM
Phase: 1
Study Start date:
January 03, 2023
Estimated Completion Date:
April 05, 2023

Study Description

Part A: Crossover IM then IV dosing with SPL026 in psychedelic experienced, healthy volunteers.

PART B: IM dosing only with SPL026 in less experienced/psychedelic naive, healthy volunteers.

Connect with a study center

  • Hammersmith Medicines Research

    London,
    United Kingdom

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.