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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05121831
Other study ID # DGX-001-01
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date February 24, 2022
Est. completion date November 6, 2022

Study information

Verified date June 2023
Source Digestome Therapeutics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 68
Est. completion date November 6, 2022
Est. primary completion date November 6, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: 1. Male or female healthy adult volunteers between 18 to 65 years of age (Both inclusive). 2. The subject's BMI is between 18 and 32 kg/m2. 3. Female subjects with childbearing potential must have a negative serum pregnancy test. 4. The subject is medically healthy with no clinically significant or relevant abnormalities in medical history, physical exam, vital signs, electrocardiogram (ECG), and laboratory evaluations (hematology, chemistry, and urinalysis) as assessed by the Investigator. Exclusion Criteria: 1. The subject has a current or recurrent disease that could affect the action, absorption or disposition of the investigational medicinal product or could affect clinical or laboratory assessments. 2. The subject has abnormal renal function test ( <60mL/min, i.e., GFR by Cockroft/Gault) at screening or baseline. 3. The subject has evidence of Gilbert's Syndrome or abnormal liver function test (LFTs >1.5x ULN) at screening or baseline. 4. The subject has had a cholecystectomy or a history of cholecystitis. 5. The subject has clinically significant 12-lead ECG abnormalities, including QTc of 450ms for males and 470ms for females (average of triplicate measures) for any pre-randomization ECG assessment. 6. The subject has a current or relevant history of physical or psychiatric illness. 7. The subject has a documented history of HIV antibody or tested positive for hepatitis B surface antigen (HBsAg) or Hepatitis C virus (HCV) antibody at screening. 8. The subject received an investigational agent within the last 30 days prior to Screening or five half-lives (if known) prior to Screening. 9. The subject has a history of alcohol or other substance abuse within the 12 months prior to dosing. 10. The subject is currently using any medication (including over-the-counter [OTC], herbal or homeopathic preparations), except for hormonal replacement therapy or hormonal contraceptives, that in the opinion of the investigator can not be discontinued and avoided for four weeks before the first dose throughout the study period.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
DGX-001Dose 1
Dose level 1 of DGX-001
DGX-001 Dose 2
Dose level 2 of DGX-001
DGX-001 Dose 3
Dose level 3 of DGX-001
DGX-001 Dose 4
Dose level 4 of DGX-001
MAD dose panel of DGX-001
Dose levels confirmed through SAD and MAD

Locations

Country Name City State
Australia CMAX Clinical Research Address Adelaide South Australia

Sponsors (1)

Lead Sponsor Collaborator
Digestome Therapeutics

Country where clinical trial is conducted

Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of treatment-emergent adverse events (TEAEs) A TEAE is any event that is not present before the initiation of the investigational product or any event already present that worsens in either intensity or frequency following exposure to the investigational product. Day1- Day14
Primary Severity of treatment-emergent adverse events as assessed by CTCAE v5.0 A TEAE is any event that is not present before the initiation of the investigational product or any event already present that worsens in either intensity or frequency following exposure to the investigational product. Day 1- Day14
Primary Number of subjects with abnormal and clinically significant safety laboratory tests Safety laboratory tests include clinical chemistry and hematology Day 1- Day 14
Primary Number of subjects with abnormal and clinically significant electrocardiogram test 12 lead ECGs will be collected in triplicate, which will measure heart rate, PR, QRS, QT, QTc Day 1- Day 21
Primary Number of subjects with abnormal and clinically significant urinalysis findings This will include routine urine test Day 1-Day 21
Secondary AUCt in SAD and MAD Total exposure Day 1-Day 9
Secondary AUC24 in SAD and MAD Area under plasma concentration -time curve at 24 hours Day 1-Day 9
Secondary AUC8 in SAD and MAD Area under plasma concentration -time from time 0 to infinity Day 1-Day 9
Secondary Cmax in SAD and MAD Maximum plasma concentration Day 1-day 9
Secondary tmax in SAD and MAD Time to maximum plasma concentration Day 1-Day 9
Secondary t1/2 in SAD and MAD Terminal elimination half-life Day 1-Day 9
Secondary CL/F in SAD and MAD Oral clearance Day 1-Day 9
Secondary Vz/F in SAD and MAD Apparent volume of distribution during terminal phase after non-intravenous administration Day 1-Day 9
Secondary ?z in SAD and MAD Elimination rate constant Day 1-Day 9
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