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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
68
Dose level 1 of DGX-001
Dose level 2 of DGX-001
Dose level 3 of DGX-001
CMAX Clinical Research Address
Adelaide, South Australia, Australia
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.
Time frame: 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.
Time frame: Day 1- Day14
Number of subjects with abnormal and clinically significant safety laboratory tests
Safety laboratory tests include clinical chemistry and hematology
Time frame: 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
Time frame: Day 1- Day 21
Number of subjects with abnormal and clinically significant urinalysis findings
This will include routine urine test
Time frame: Day 1-Day 21
AUCt in SAD and MAD
Total exposure
Time frame: Day 1-Day 9
AUC24 in SAD and MAD
Area under plasma concentration -time curve at 24 hours
Time frame: Day 1-Day 9
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Dose level 4 of DGX-001
Dose levels confirmed through SAD and MAD
AUC∞ in SAD and MAD
Area under plasma concentration -time from time 0 to infinity
Time frame: Day 1-Day 9
Cmax in SAD and MAD
Maximum plasma concentration
Time frame: Day 1-day 9
tmax in SAD and MAD
Time to maximum plasma concentration
Time frame: Day 1-Day 9
t1/2 in SAD and MAD
Terminal elimination half-life
Time frame: Day 1-Day 9
CL/F in SAD and MAD
Oral clearance
Time frame: Day 1-Day 9
Vz/F in SAD and MAD
Apparent volume of distribution during terminal phase after non-intravenous administration
Time frame: Day 1-Day 9
λz in SAD and MAD
Elimination rate constant
Time frame: Day 1-Day 9