Depressive DisorderPhase 1NCT05121831

A First in Human Study to Assess the Safety, Tolerability, and Pharmacokinetics of DGX-001

A Phase 1 study testing DGX-001Dose 1, DGX-001 Dose 2 and DGX-001 Dose 3 in people with Depressive Disorder, run by Digestome Therapeutics at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Depressive Disorder
What is being tested?: DGX-001Dose 1, DGX-001 Dose 2 and DGX-001 Dose 3
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 68 participants
Where: 1 siteAustralia
Study dates: 24 Feb 2022to 6 Nov 2022
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

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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.

Trial locations and contacts

1 site in 1 country.

Australia1 site

CMAX Clinical Research Address
Adelaide, South Australia, 5000

Other trials in Australia

About this study

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

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.

Read the 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.

Conditions: Depressive Disorder
Being tested: DGX-001Dose 1, DGX-001 Dose 2, DGX-001 Dose 3, DGX-001 Dose 4, MAD dose panel of DGX-001
Medical subject headings: Depressive Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT05121831
Study group	Role	What they receive
Single Ascending Dose Cohort S1	Experimental	Subjects will receive a single dose of either dose level 1 of DGX-001 or placebo Receives: Drug: DGX-001Dose 1
Single Ascending Dose Cohort S2	Experimental	Subjects will receive a single dose of either dose level 2 of DGX-001 or placebo Receives: Drug: DGX-001 Dose 2
Single Ascending Dose Cohort S3	Experimental	Subjects will receive a single dose of either dose level 3 of DGX-001 or placebo Receives: Drug: DGX-001 Dose 3
Single Ascending Dose Cohort S4	Experimental	Subjects will receive a single dose of either dose level 4 of DGX-001 or placebo Receives: Drug: DGX-001 Dose 4
Multiple Ascending Doses Cohort M1	Experimental	Subjects will receive multiple doses of either dose level 1 of DGX-001 or placebo Receives: Drug: DGX-001Dose 1
Multiple Ascending Doses Cohort M2	Experimental	Subjects will receive multiple doses of either dose level 2 of DGX-001 or placebo Receives: Drug: DGX-001 Dose 2
Multiple Ascending Doses Cohort M3	Experimental	Subjects will receive multiple doses of either dose level 3 of DGX-001 or placebo Receives: Drug: DGX-001 Dose 3
Stress Exposure Resilience Panel Cohort 1	Experimental	Subjects will receive any of the MAD dose panel or placebo Receives: Drug: MAD dose panel of DGX-001

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Day1- Day14
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.
Measured: Day 1- Day14
Number of subjects with abnormal and clinically significant safety laboratory tests
Safety laboratory tests include clinical chemistry and hematology
Measured: Day 1- Day 14
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
Measured: Day 1- Day 21
Number of subjects with abnormal and clinically significant urinalysis findings
This will include routine urine test
Measured: Day 1-Day 21

Secondary outcomes (9)

AUCt in SAD and MAD
Total exposure
Measured: Day 1-Day 9
AUC24 in SAD and MAD
Area under plasma concentration -time curve at 24 hours
Measured: Day 1-Day 9
AUC∞ in SAD and MAD
Area under plasma concentration -time from time 0 to infinity
Measured: Day 1-Day 9
Cmax in SAD and MAD
Maximum plasma concentration
Measured: Day 1-day 9
tmax in SAD and MAD
Time to maximum plasma concentration
Measured: Day 1-Day 9
t1/2 in SAD and MAD
Terminal elimination half-life
Measured: Day 1-Day 9
CL/F in SAD and MAD
Oral clearance
Measured: Day 1-Day 9
Vz/F in SAD and MAD
Apparent volume of distribution during terminal phase after non-intravenous administration
Measured: Day 1-Day 9
λz in SAD and MAD
Elimination rate constant
Measured: Day 1-Day 9

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Feb 20226 Nov 2022

First posted16 Nov 2021
Study start24 Feb 2022
Primary completion6 Nov 2022
Study completion6 Nov 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Depressive DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
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: Double blind
Who is masked: Participant, Investigator
Enrolment: 68 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05121831
Sponsor's protocol ID: DGX-001-01
Status last verified: Jun 2023
First submitted: 5 Nov 2021
Last updated: 22 Jun 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Depressive Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05121831
Acronym / sponsor ID: DGX-001-01
Conditions: Depressive Disorder
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 68 participants (actual)
Lead sponsor: Digestome TherapeuticsIndustry (pharma, biotech, devices)
Study start: 24 Feb 2022 (actual)
Primary completion: 6 Nov 2022 (actual)
Study completion: 6 Nov 2022 (actual)
First posted: 16 Nov 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind (participant, investigator)
Number of arms: 8
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.

Arm	Type	Receives
Single Ascending Dose Cohort S1	Experimental	Drug: DGX-001Dose 1Subjects will receive a single dose of either dose level 1 of DGX-001 or placebo
Single Ascending Dose Cohort S2	Experimental	Drug: DGX-001 Dose 2Subjects will receive a single dose of either dose level 2 of DGX-001 or placebo
Single Ascending Dose Cohort S3	Experimental	Drug: DGX-001 Dose 3Subjects will receive a single dose of either dose level 3 of DGX-001 or placebo
Single Ascending Dose Cohort S4	Experimental	Drug: DGX-001 Dose 4Subjects will receive a single dose of either dose level 4 of DGX-001 or placebo
Multiple Ascending Doses Cohort M1	Experimental	Drug: DGX-001Dose 1Subjects will receive multiple doses of either dose level 1 of DGX-001 or placebo
Multiple Ascending Doses Cohort M2	Experimental	Drug: DGX-001 Dose 2Subjects will receive multiple doses of either dose level 2 of DGX-001 or placebo
Multiple Ascending Doses Cohort M3	Experimental	Drug: DGX-001 Dose 3Subjects will receive multiple doses of either dose level 3 of DGX-001 or placebo
Stress Exposure Resilience Panel Cohort 1	Experimental	Drug: MAD dose panel of DGX-001Subjects will receive any of the MAD dose panel or placebo

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (10 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DGX-001Dose 1Also: DGX-001Dose level 1 of DGX-001	Drug	Multiple Ascending Doses Cohort M1, Single Ascending Dose Cohort S1
DGX-001 Dose 2Also: DGX-001Dose level 2 of DGX-001	Drug	Multiple Ascending Doses Cohort M2, Single Ascending Dose Cohort S2
DGX-001 Dose 3Also: DGX-001Dose level 3 of DGX-001	Drug	Multiple Ascending Doses Cohort M3, Single Ascending Dose Cohort S3
DGX-001 Dose 4Also: DGX-001Dose level 4 of DGX-001	Drug	Single Ascending Dose Cohort S4
MAD dose panel of DGX-001Also: DGX-001Dose levels confirmed through SAD and MAD	Drug	Stress Exposure Resilience Panel Cohort 1

Primary outcome

Number of treatment-emergent adverse events (TEAEs)
Time frame: Day1- Day14
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
Time frame: Day 1- Day14
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
Time frame: Day 1- Day 14
Safety laboratory tests include clinical chemistry and hematology
Number of subjects with abnormal and clinically significant electrocardiogram test
Time frame: Day 1- Day 21
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
Time frame: Day 1-Day 21
This will include routine urine test

9 secondary outcomes

AUCt in SAD and MAD
Time frame: Day 1-Day 9
AUC24 in SAD and MAD
Time frame: Day 1-Day 9
AUC∞ in SAD and MAD
Time frame: Day 1-Day 9
Cmax in SAD and MAD
Time frame: Day 1-day 9
tmax in SAD and MAD
Time frame: Day 1-Day 9
t1/2 in SAD and MAD
Time frame: Day 1-Day 9
CL/F in SAD and MAD
Time frame: Day 1-Day 9
Vz/F in SAD and MAD
Time frame: Day 1-Day 9
λz in SAD and MAD
Time frame: Day 1-Day 9

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing DGX-001Dose 1, DGX-001 Dose 2 and DGX-001 Dose 3 in people with Depressive Disorder, run by Digestome Therapeutics at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of treatment-emergent adverse events (TEAEs) (time frame: Day1- Day14). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05121831.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.