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A First in Human Study to Assess the Safety, Tolerability, and Pharmacokinetics of DGX-001

NCT05121831 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2023-06-22

No results posted yet for this study

Summary

This is a phase 1, randomized, double-blind, placebo-controlled, SAD and MAD study in healthy adult volunteers. DGX-001 is a peptide being investigated for the treatment of the major depressive disorder. This study will examine the safety and tolerability of increasing doses of DGX-001 and, in an exploratory way, potential moderators and functional markers of its activity.

Conditions

  • Depressive Disorder

Interventions

DRUG

DGX-001Dose 1

Dose level 1 of DGX-001

DRUG

DGX-001 Dose 2

Dose level 2 of DGX-001

DRUG

DGX-001 Dose 3

Dose level 3 of DGX-001

DRUG

DGX-001 Dose 4

Dose level 4 of DGX-001

DRUG

MAD dose panel of DGX-001

Dose levels confirmed through SAD and MAD

Sponsors & Collaborators

  • Digestome Therapeutics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2022-02-24
Primary Completion
2022-11-06
Completion
2022-11-06

Countries

  • Australia

Study Locations

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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 NCT05121831 on ClinicalTrials.gov