Back to resultsA First in Human Study to Assess the Safety, Tolerability, and Pharmacokinetics of DGX-001
Primary Purpose
Depressive Disorder
Status
Completed
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
DGX-001Dose 1
DGX-001 Dose 2
DGX-001 Dose 3
DGX-001 Dose 4
MAD dose panel of DGX-001
Sponsored by
About this trial
This is an interventional treatment trial for Depressive Disorder
Eligibility Criteria
Inclusion Criteria:
- Male or female healthy adult volunteers between 18 to 65 years of age (Both inclusive).
- The subject's BMI is between 18 and 32 kg/m2.
- Female subjects with childbearing potential must have a negative serum pregnancy test.
- 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:
- 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.
- The subject has abnormal renal function test ( <60mL/min, i.e., GFR by Cockroft/Gault) at screening or baseline.
- The subject has evidence of Gilbert's Syndrome or abnormal liver function test (LFTs >1.5x ULN) at screening or baseline.
- The subject has had a cholecystectomy or a history of cholecystitis.
- 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.
- The subject has a current or relevant history of physical or psychiatric illness.
- 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.
- The subject received an investigational agent within the last 30 days prior to Screening or five half-lives (if known) prior to Screening.
- The subject has a history of alcohol or other substance abuse within the 12 months prior to dosing.
- 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.
Sites / Locations
- CMAX Clinical Research Address
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Single Ascending Dose Cohort S1
Single Ascending Dose Cohort S2
Single Ascending Dose Cohort S3
Single Ascending Dose Cohort S4
Multiple Ascending Doses Cohort M1
Multiple Ascending Doses Cohort M2
Multiple Ascending Doses Cohort M3
Stress Exposure Resilience Panel Cohort 1
Arm Description
Subjects will receive a single dose of either dose level 1 of DGX-001 or placebo
Subjects will receive a single dose of either dose level 2 of DGX-001 or placebo
Subjects will receive a single dose of either dose level 3 of DGX-001 or placebo
Subjects will receive a single dose of either dose level 4 of DGX-001 or placebo
Subjects will receive multiple doses of either dose level 1 of DGX-001 or placebo
Subjects will receive multiple doses of either dose level 2 of DGX-001 or placebo
Subjects will receive multiple doses of either dose level 3 of DGX-001 or placebo
Subjects will receive any of the MAD dose panel or placebo
Outcomes
Primary Outcome Measures
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.
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.
Number of subjects with abnormal and clinically significant safety laboratory tests
Safety laboratory tests include clinical chemistry and hematology
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
Number of subjects with abnormal and clinically significant urinalysis findings
This will include routine urine test
Secondary Outcome Measures
AUCt in SAD and MAD
Total exposure
AUC24 in SAD and MAD
Area under plasma concentration -time curve at 24 hours
AUC∞ in SAD and MAD
Area under plasma concentration -time from time 0 to infinity
Cmax in SAD and MAD
Maximum plasma concentration
tmax in SAD and MAD
Time to maximum plasma concentration
t1/2 in SAD and MAD
Terminal elimination half-life
CL/F in SAD and MAD
Oral clearance
Vz/F in SAD and MAD
Apparent volume of distribution during terminal phase after non-intravenous administration
λz in SAD and MAD
Elimination rate constant
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05121831
Brief Title
A First in Human Study to Assess the Safety, Tolerability, and Pharmacokinetics of DGX-001
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
February 24, 2022 (Actual)
Primary Completion Date
November 6, 2022 (Actual)
Study Completion Date
November 6, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Digestome Therapeutics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Model Description
Part 1 and Part 2 of the study will have a parallel assignment and Part 3 of the study will have a parallel assignment with a crossover design.
Masking
ParticipantInvestigator
Masking Description
Double-blind
Allocation
Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single Ascending Dose Cohort S1
Arm Type
Experimental
Arm Description
Subjects will receive a single dose of either dose level 1 of DGX-001 or placebo
Arm Title
Single Ascending Dose Cohort S2
Arm Type
Experimental
Arm Description
Subjects will receive a single dose of either dose level 2 of DGX-001 or placebo
Arm Title
Single Ascending Dose Cohort S3
Arm Type
Experimental
Arm Description
Subjects will receive a single dose of either dose level 3 of DGX-001 or placebo
Arm Title
Single Ascending Dose Cohort S4
Arm Type
Experimental
Arm Description
Subjects will receive a single dose of either dose level 4 of DGX-001 or placebo
Arm Title
Multiple Ascending Doses Cohort M1
Arm Type
Experimental
Arm Description
Subjects will receive multiple doses of either dose level 1 of DGX-001 or placebo
Arm Title
Multiple Ascending Doses Cohort M2
Arm Type
Experimental
Arm Description
Subjects will receive multiple doses of either dose level 2 of DGX-001 or placebo
Arm Title
Multiple Ascending Doses Cohort M3
Arm Type
Experimental
Arm Description
Subjects will receive multiple doses of either dose level 3 of DGX-001 or placebo
Arm Title
Stress Exposure Resilience Panel Cohort 1
Arm Type
Experimental
Arm Description
Subjects will receive any of the MAD dose panel or placebo
Intervention Type
Drug
Intervention Name(s)
DGX-001Dose 1
Other Intervention Name(s)
DGX-001
Intervention Description
Dose level 1 of DGX-001
Intervention Type
Drug
Intervention Name(s)
DGX-001 Dose 2
Other Intervention Name(s)
DGX-001
Intervention Description
Dose level 2 of DGX-001
Intervention Type
Drug
Intervention Name(s)
DGX-001 Dose 3
Other Intervention Name(s)
DGX-001
Intervention Description
Dose level 3 of DGX-001
Intervention Type
Drug
Intervention Name(s)
DGX-001 Dose 4
Other Intervention Name(s)
DGX-001
Intervention Description
Dose level 4 of DGX-001
Intervention Type
Drug
Intervention Name(s)
MAD dose panel of DGX-001
Other Intervention Name(s)
DGX-001
Intervention Description
Dose levels confirmed through SAD and MAD
Primary Outcome Measure Information:
Title
Number of treatment-emergent adverse events (TEAEs)
Description
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.
Time Frame
Day1- Day14
Title
Severity of treatment-emergent adverse events as assessed by CTCAE v5.0
Description
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.
Time Frame
Day 1- Day14
Title
Number of subjects with abnormal and clinically significant safety laboratory tests
Description
Safety laboratory tests include clinical chemistry and hematology
Time Frame
Day 1- Day 14
Title
Number of subjects with abnormal and clinically significant electrocardiogram test
Description
12 lead ECGs will be collected in triplicate, which will measure heart rate, PR, QRS, QT, QTc
Time Frame
Day 1- Day 21
Title
Number of subjects with abnormal and clinically significant urinalysis findings
Description
This will include routine urine test
Time Frame
Day 1-Day 21
Secondary Outcome Measure Information:
Title
AUCt in SAD and MAD
Description
Total exposure
Time Frame
Day 1-Day 9
Title
AUC24 in SAD and MAD
Description
Area under plasma concentration -time curve at 24 hours
Time Frame
Day 1-Day 9
Title
AUC∞ in SAD and MAD
Description
Area under plasma concentration -time from time 0 to infinity
Time Frame
Day 1-Day 9
Title
Cmax in SAD and MAD
Description
Maximum plasma concentration
Time Frame
Day 1-day 9
Title
tmax in SAD and MAD
Description
Time to maximum plasma concentration
Time Frame
Day 1-Day 9
Title
t1/2 in SAD and MAD
Description
Terminal elimination half-life
Time Frame
Day 1-Day 9
Title
CL/F in SAD and MAD
Description
Oral clearance
Time Frame
Day 1-Day 9
Title
Vz/F in SAD and MAD
Description
Apparent volume of distribution during terminal phase after non-intravenous administration
Time Frame
Day 1-Day 9
Title
λz in SAD and MAD
Description
Elimination rate constant
Time Frame
Day 1-Day 9
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male or female healthy adult volunteers between 18 to 65 years of age (Both inclusive).
The subject's BMI is between 18 and 32 kg/m2.
Female subjects with childbearing potential must have a negative serum pregnancy test.
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:
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.
The subject has abnormal renal function test ( <60mL/min, i.e., GFR by Cockroft/Gault) at screening or baseline.
The subject has evidence of Gilbert's Syndrome or abnormal liver function test (LFTs >1.5x ULN) at screening or baseline.
The subject has had a cholecystectomy or a history of cholecystitis.
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.
The subject has a current or relevant history of physical or psychiatric illness.
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.
The subject received an investigational agent within the last 30 days prior to Screening or five half-lives (if known) prior to Screening.
The subject has a history of alcohol or other substance abuse within the 12 months prior to dosing.
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.
Facility Information:
Facility Name
CMAX Clinical Research Address
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A First in Human Study to Assess the Safety, Tolerability, and Pharmacokinetics of DGX-001
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