A First in Human Study to Assess the Safety, Tolerability, and Pharmacokinetics of DGX-001 - Trial NCT05121831
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.
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Study Focus
Sponsor & Location
Digestome Therapeutics
Timeline & Enrollment
Phase 1
Feb 24, 2022
Nov 06, 2022
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
Data Source
ClinicalTrials.gov
NCT05121831
Non-Device Trial