Depressive Disorder Clinical Trial
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
Verified date | June 2023 |
Source | Digestome Therapeutics |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Australia | CMAX Clinical Research Address | Adelaide | South Australia |
Lead Sponsor | Collaborator |
---|---|
Digestome Therapeutics |
Australia,
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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