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A Study of a Psilocybin Analog (CYB003) in Healthy Participants With and Without Major Depressive Disorder

NCT05385783 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2024-03-25

No results posted yet for this study

Summary

The purpose of this study is to determine the safety and tolerability of ascending oral doses of CYB003 in healthy participants with and without major depressive disorder (MDD).

Conditions

Interventions

DRUG

CYB003

CYB003 is a synthetic psilocybin analog.

BEHAVIORAL

Psychotherapy

Manualized psychotherapy (called EMBARK) performed by facilitators

DRUG

Placebo

Placebo

BEHAVIORAL

Psychological Support

Manualized psychological support performed by facilitators

Sponsors & Collaborators

  • Clinilabs Drug Development Corporation

    collaborator UNKNOWN

  • Drug Safety Navigator

    collaborator UNKNOWN

  • Cybin IRL Limited

    lead INDUSTRY

Principal Investigators

  • Amir Inamdar, MBBS,DNB,MFPM · Cybin IRL Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-02
Primary Completion
2023-10-16
Completion
2024-01-18
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05385783 on ClinicalTrials.gov