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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05121831
Registration number
NCT05121831
Ethics application status
Date submitted
5/11/2021
Date registered
16/11/2021
Date last updated
22/06/2023
Titles & IDs
Public title
A First in Human Study to Assess the Safety, Tolerability, and Pharmacokinetics of DGX-001
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Scientific title
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
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Secondary ID [1]
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DGX-001-01
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Depressive Disorder
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Condition category
Condition code
Mental Health
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Depression
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - DGX-001Dose 1
Treatment: Drugs - DGX-001 Dose 2
Treatment: Drugs - DGX-001 Dose 3
Treatment: Drugs - DGX-001 Dose 4
Treatment: Drugs - MAD dose panel of DGX-001
Experimental: Single Ascending Dose Cohort S1 - Subjects will receive a single dose of either dose level 1 of DGX-001 or placebo
Experimental: Single Ascending Dose Cohort S2 - Subjects will receive a single dose of either dose level 2 of DGX-001 or placebo
Experimental: Single Ascending Dose Cohort S3 - Subjects will receive a single dose of either dose level 3 of DGX-001 or placebo
Experimental: Single Ascending Dose Cohort S4 - Subjects will receive a single dose of either dose level 4 of DGX-001 or placebo
Experimental: Multiple Ascending Doses Cohort M1 - Subjects will receive multiple doses of either dose level 1 of DGX-001 or placebo
Experimental: Multiple Ascending Doses Cohort M2 - Subjects will receive multiple doses of either dose level 2 of DGX-001 or placebo
Experimental: Multiple Ascending Doses Cohort M3 - Subjects will receive multiple doses of either dose level 3 of DGX-001 or placebo
Experimental: Stress Exposure Resilience Panel Cohort 1 - Subjects will receive any of the MAD dose panel or placebo
Treatment: Drugs: DGX-001Dose 1
Dose level 1 of DGX-001
Treatment: Drugs: DGX-001 Dose 2
Dose level 2 of DGX-001
Treatment: Drugs: DGX-001 Dose 3
Dose level 3 of DGX-001
Treatment: Drugs: DGX-001 Dose 4
Dose level 4 of DGX-001
Treatment: Drugs: MAD dose panel of DGX-001
Dose levels confirmed through SAD and MAD
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of treatment-emergent adverse events (TEAEs)
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Assessment method [1]
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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.
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Timepoint [1]
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Day1- Day14
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Primary outcome [2]
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Severity of treatment-emergent adverse events as assessed by CTCAE v5.0
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Assessment method [2]
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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.
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Timepoint [2]
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Day 1- Day14
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Primary outcome [3]
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Number of subjects with abnormal and clinically significant safety laboratory tests
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Assessment method [3]
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Safety laboratory tests include clinical chemistry and hematology
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Timepoint [3]
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Day 1- Day 14
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Primary outcome [4]
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Number of subjects with abnormal and clinically significant electrocardiogram test
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Assessment method [4]
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12 lead ECGs will be collected in triplicate, which will measure heart rate, PR, QRS, QT, QTc
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Timepoint [4]
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Day 1- Day 21
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Primary outcome [5]
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Number of subjects with abnormal and clinically significant urinalysis findings
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Assessment method [5]
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This will include routine urine test
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Timepoint [5]
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Day 1-Day 21
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Secondary outcome [1]
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AUCt in SAD and MAD
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Assessment method [1]
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Total exposure
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Timepoint [1]
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Day 1-Day 9
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Secondary outcome [2]
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AUC24 in SAD and MAD
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Assessment method [2]
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Area under plasma concentration -time curve at 24 hours
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Timepoint [2]
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Day 1-Day 9
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Secondary outcome [3]
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AUC8 in SAD and MAD
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Assessment method [3]
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Area under plasma concentration -time from time 0 to infinity
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Timepoint [3]
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Day 1-Day 9
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Secondary outcome [4]
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Cmax in SAD and MAD
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Assessment method [4]
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Maximum plasma concentration
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Timepoint [4]
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Day 1-day 9
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Secondary outcome [5]
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tmax in SAD and MAD
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Assessment method [5]
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Time to maximum plasma concentration
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Timepoint [5]
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Day 1-Day 9
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Secondary outcome [6]
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t1/2 in SAD and MAD
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Assessment method [6]
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Terminal elimination half-life
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Timepoint [6]
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Day 1-Day 9
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Secondary outcome [7]
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CL/F in SAD and MAD
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Assessment method [7]
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Oral clearance
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Timepoint [7]
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Day 1-Day 9
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Secondary outcome [8]
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Vz/F in SAD and MAD
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Assessment method [8]
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Apparent volume of distribution during terminal phase after non-intravenous administration
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Timepoint [8]
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Day 1-Day 9
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Secondary outcome [9]
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?z in SAD and MAD
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Assessment method [9]
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Elimination rate constant
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Timepoint [9]
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Day 1-Day 9
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
24/02/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
6/11/2022
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Sample size
Target
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Accrual to date
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Final
68
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
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CMAX Clinical Research Address - Adelaide
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Recruitment postcode(s) [1]
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5000 - Adelaide
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Digestome Therapeutics
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/study/NCT05121831
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05121831
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