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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

Titles & IDs
Public title
A First in Human Study to Assess the Safety, Tolerability, and Pharmacokinetics of DGX-001
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
Secondary ID [1] 0 0
DGX-001-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depressive Disorder 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Depression

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of treatment-emergent adverse events (TEAEs)
Timepoint [1] 0 0
Day1- Day14
Primary outcome [2] 0 0
Severity of treatment-emergent adverse events as assessed by CTCAE v5.0
Timepoint [2] 0 0
Day 1- Day14
Primary outcome [3] 0 0
Number of subjects with abnormal and clinically significant safety laboratory tests
Timepoint [3] 0 0
Day 1- Day 14
Primary outcome [4] 0 0
Number of subjects with abnormal and clinically significant electrocardiogram test
Timepoint [4] 0 0
Day 1- Day 21
Primary outcome [5] 0 0
Number of subjects with abnormal and clinically significant urinalysis findings
Timepoint [5] 0 0
Day 1-Day 21
Secondary outcome [1] 0 0
AUCt in SAD and MAD
Timepoint [1] 0 0
Day 1-Day 9
Secondary outcome [2] 0 0
AUC24 in SAD and MAD
Timepoint [2] 0 0
Day 1-Day 9
Secondary outcome [3] 0 0
AUC8 in SAD and MAD
Timepoint [3] 0 0
Day 1-Day 9
Secondary outcome [4] 0 0
Cmax in SAD and MAD
Timepoint [4] 0 0
Day 1-day 9
Secondary outcome [5] 0 0
tmax in SAD and MAD
Timepoint [5] 0 0
Day 1-Day 9
Secondary outcome [6] 0 0
t1/2 in SAD and MAD
Timepoint [6] 0 0
Day 1-Day 9
Secondary outcome [7] 0 0
CL/F in SAD and MAD
Timepoint [7] 0 0
Day 1-Day 9
Secondary outcome [8] 0 0
Vz/F in SAD and MAD
Timepoint [8] 0 0
Day 1-Day 9
Secondary outcome [9] 0 0
?z in SAD and MAD
Timepoint [9] 0 0
Day 1-Day 9

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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/02/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
6/11/2022
Sample size
Target
Accrual to date
Final
68
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
CMAX Clinical Research Address - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Digestome Therapeutics
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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