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Clinical Trial 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.

Clinical Trial Description

The study will be conducted in three parts, Part 1 consisting of SAD cohorts and Part 2 consisting of MAD cohorts and Part 3 consisting of two cohorts of stress exposure resilience panel. In Part 1, approximately 32 adult healthy volunteers will be enrolled sequentially into 1 of 4 single-dose cohorts and will be randomized to receive either a dose of DGX-001 or a placebo. In Part 2, approximately 24 adult healthy volunteers will be enrolled into 1 of 3 multiple-dose cohorts. An adaptive dose-escalation schedule will be employed for both the SAD and MAD parts of the study. In Part 3, 28 subjects will be enrolled into 1 of 2 cohorts to further explore the pharmacodynamic effect of DGX-001 under a physiological challenge. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05121831
Study type Interventional
Source Digestome Therapeutics
Contact Igor Grachev
Phone 1-732-642-7773
Email [email protected]
Status Not yet recruiting
Phase Phase 1
Start date January 11, 2022
Completion date November 10, 2022

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