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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
Digestome Therapeutics·Phase 1·ClinicalTrials.gov·drugCompleted
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Study focus
Disease/Condition
Depressive Disorder
Drug/Device/Intervention
DGX-001Dose 1
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Digestome Therapeutics
Location
Adelaide, Australia
Timeline & enrollment
Phase
Phase 1
Start date
Feb 24, 2022
End date
Nov 06, 2022
Enrollment
68 participants
Primary outcome

Number of treatment-emergent adverse events (TEAEs),Severity of treatment-emergent adverse events as assessed by CTCAE v5.0,Number of subjects with abnormal and clinically significant safety laboratory tests,Number of subjects with abnormal and clinically significant electrocardiogram test,Number of subjects with abnormal and clinically significant urinalysis findings

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.

ICD-10 classifications
Depressive conduct disorderRecurrent depressive disorder, unspecifiedRecurrent depressive disorderOther recurrent depressive disordersRecurrent depressive disorder, currently in remission
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05121831
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05121831 through Pure Global AI's free database. This Phase 1 trial is sponsored by Digestome Therapeutics and is currently Completed. The study focuses on Depressive Disorder. Target enrollment is 68 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.