NCT05121831 is a Phase 1 clinical trial of DGX-001Dose 1 in Depressive Disorder, sponsored by Digestome Therapeutics.

Who is sponsoring NCT05121831?

NCT05121831 is sponsored by Digestome Therapeutics.

What drugs are being tested in NCT05121831?

Interventions in NCT05121831: DGX-001Dose 1, DGX-001 Dose 2, DGX-001 Dose 3, DGX-001 Dose 4, MAD dose panel of DGX-001.

What condition does NCT05121831 study?

NCT05121831 studies Depressive Disorder.

Is NCT05121831 still recruiting?

NCT05121831 is currently completed. Last updated 22 June 2023.

Last reviewed 2023-06-22 · How we verify

NCT05121831

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Last updated 22 June 2023

What this trial tests

Phase 1 trial testing DGX-001Dose 1 in Depressive Disorder in 68 participants. Completed in 6 November 2022.

Timeline

24 February 2022

Primary endpoint
6 November 2022

6 November 2022

Quick facts

Lead sponsor	Digestome Therapeutics
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	double
Primary purpose	treatment
Enrollment	68
Start date	24 February 2022
Primary completion	6 November 2022
Estimated completion	6 November 2022
Sites	1 location across Australia

Drugs / interventions tested

DGX-001Dose 1 — full drug profile →
DGX-001 Dose 2 — full drug profile →
DGX-001 Dose 3
DGX-001 Dose 4
MAD dose panel of DGX-001 — full drug profile →

Conditions studied

Depressive Disorder — all drugs for Depressive Disorder →

Sponsor

Digestome Therapeutics — full company profile →

Who can join

Adults 18 to 65, any sex, with Depressive Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05121831 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Digestome Therapeutics
Last refreshed: 22 June 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05121831.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing