NCT05121831

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

A Phase 1, Randomized, Double-blind, Placebo-controlled, Safety, Tolerability and Pharmacokinetic Study of Escalating Single and Multiple Doses of DGX-001 in Healthy Volunteers Followed by a Stress Exposure Resilience Panel

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Digestome Therapeutics · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed 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 one 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, 14 subjects will be enrolled in 1 cohorts to further explore the pharmacodynamic effect of DGX-001 under a physiological challenge.

Conditions

• Depressive Disorder

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-02-24
• Primary completion: 2022-11-06
• Completion: 2022-11-06
• First posted: 2021-11-16
• Last updated: 2023-06-22

Locations

1 site across 1 country: Australia