A First in Human Study to Assess the Safety, Tolerability, and Pharmacokinetics of DGX-001
- Conditions
- Depressive Disorder
- Interventions
- Drug: DGX-001 Dose 2Drug: MAD dose panel of DGX-001Drug: DGX-001 Dose 3Drug: DGX-001Dose 1Drug: DGX-001 Dose 4
- Registration Number
- NCT05121831
- Lead Sponsor
- Digestome Therapeutics
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 68
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Single Ascending Dose Cohort S2 DGX-001 Dose 2 Subjects will receive a single dose of either dose level 2 of DGX-001 or placebo Multiple Ascending Doses Cohort M2 DGX-001 Dose 2 Subjects will receive multiple doses of either dose level 2 of DGX-001 or placebo Stress Exposure Resilience Panel Cohort 1 MAD dose panel of DGX-001 Subjects will receive any of the MAD dose panel or placebo Multiple Ascending Doses Cohort M3 DGX-001 Dose 3 Subjects will receive multiple doses of either dose level 3 of DGX-001 or placebo Multiple Ascending Doses Cohort M1 DGX-001Dose 1 Subjects will receive multiple doses of either dose level 1 of DGX-001 or placebo Single Ascending Dose Cohort S1 DGX-001Dose 1 Subjects will receive a single dose of either dose level 1 of DGX-001 or placebo Single Ascending Dose Cohort S3 DGX-001 Dose 3 Subjects will receive a single dose of either dose level 3 of DGX-001 or placebo Single Ascending Dose Cohort S4 DGX-001 Dose 4 Subjects will receive a single dose of either dose level 4 of DGX-001 or placebo
- Primary Outcome Measures
Name Time Method Number of treatment-emergent adverse events (TEAEs) 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 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 Day 1- Day 14 Safety laboratory tests include clinical chemistry and hematology
Number of subjects with abnormal and clinically significant electrocardiogram test 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 Day 1-Day 21 This will include routine urine test
- Secondary Outcome Measures
Name Time Method Cmax in SAD and MAD Day 1-day 9 Maximum plasma concentration
CL/F in SAD and MAD Day 1-Day 9 Oral clearance
AUCt in SAD and MAD Day 1-Day 9 Total exposure
AUC24 in SAD and MAD Day 1-Day 9 Area under plasma concentration -time curve at 24 hours
tmax in SAD and MAD Day 1-Day 9 Time to maximum plasma concentration
AUC∞ in SAD and MAD Day 1-Day 9 Area under plasma concentration -time from time 0 to infinity
t1/2 in SAD and MAD Day 1-Day 9 Terminal elimination half-life
Vz/F in SAD and MAD Day 1-Day 9 Apparent volume of distribution during terminal phase after non-intravenous administration
λz in SAD and MAD Day 1-Day 9 Elimination rate constant
Trial Locations
- Locations (1)
CMAX Clinical Research Address
🇦🇺Adelaide, South Australia, Australia