This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose and multiple ascending dose study of ECC5004 in healthy participants and in patients with Type 2 Diabetes Mellitus
This study will be conducted in two cohorts of Single Ascending Dose (SAD) with a dose range from 1mg to 300mg, and in four cohorts of Multiple Ascending Dose (MAD) with a dose range of 10mg to 150mg to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ECC5004 in Healthy Participants and in Patients with Type 2 Diabetes Mellitus
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
69
Eccogene Investigational Site
Anaheim, California, United States
Number of participants with adverse events, with abnormal laboratory test results, abnormal ECGs, abnormal vital signs, and abnormal physical examinations
Safety Assessment evaluated through adverse events, laboratory evaluations, vital signs, ECGs, and physical examination.
Time frame: SAD: Up to Day 8 and MAD: Up to Day 35
Pharmacokinetic Parameters: AUC0-24
AUC from time 0 to 24 hour dosing interval
Time frame: SAD: Up to Day 3 and MAD: Up to Day 30
Pharmacokinetic Parameters: AUC0-tlast
AUC from time 0 to the time of last quantifiable non-zero concentration
Time frame: SAD: Up to Day 3
Pharmacokinetic Parameters: AUC0-tau
AUC over a dosing interval from time 0 to time of last quantifiable concentration
Time frame: MAD: Up to Day 30
Pharmacokinetic Parameters: AUC0-infinity
AUC from time 0 extrapolated to infinity
Time frame: SAD: Up to Day 3
Pharmacokinetic Parameters: Cmax
Maximum observed plasma concentration
Time frame: SAD: Up to Day 3 and MAD: Up to Day 30
Pharmacokinetic Parameters: C24
Observed concentration at 24 hours post dose
Time frame: SAD: Up to Day 3 and MAD: Up to Day 30
Pharmacokinetic Parameters: Ctau
Observed concentration at the end of the dosing interval
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Time frame: MAD: Up to Day 30
Pharmacokinetic Parameters: tmax
Time of the maximum observed plasma concentration
Time frame: SAD: Up to Day 3 and MAD: Up to Day 30
Pharmacokinetic Parameters: tlag
Lag time (time delay between dosing and first observed plasma concentration)
Time frame: SAD: Up to Day 3 and MAD: Up to Day 30
Pharmacokinetic Parameters: t1/2
Apparent terminal elimination half-life
Time frame: SAD: Up to Day 3 and MAD: Up to Day 30
Pharmacokinetic Parameters: Clast
Last measurable non-zero concentration
Time frame: SAD: Up to Day 3
Pharmacokinetic Parameters: tlast
Time of last measurable non-zero concentration
Time frame: SAD: Up to Day 3
Pharmacokinetic Parameters: CL/F
Apparent Clearance
Time frame: SAD: Up to Day 3 and MAD: Up to Day 30
Pharmacodynamic Parameters: AUC0-4 for glucose
AUC from time 0 to 4 hour dosing interval
Time frame: MAD: Up to Day 30
Pharmacodynamic Parameters: AUC0-4 for insulin
AUC from time 0 to 4 hour dosing interval
Time frame: MAD: Up to Day 30
Pharmacodynamic Parameters: AUC0-4 for glucagon
AUC from time 0 to 4 hour dosing interval
Time frame: MAD: Up to Day 30
Pharmacodynamic Parameters: AUC0-4 for C-peptide
AUC from time 0 to 4 hour dosing interval
Time frame: MAD: Up to Day 30
Pharmacodynamic Parameters: Fasting plasma glucose
Change from baseline
Time frame: MAD: Up to Day 30
Pharmacodynamic Parameters: Mean daily glucose
Change from baseline
Time frame: MAD: Up to Day 30
Pharmacodynamic Parameters: Body Weight and Waist Circumference
Change from baseline
Time frame: MAD: Up to Day 30
Pharmacodynamic Parameters: Fasting plasma glucose homeostatic model assessment
Fasting plasma glucose homeostatic model assessment
Time frame: MAD: Up to Day 30
Pharmacodynamic Parameters: Fasting plasma insulin homeostatic model assessment
Fasting plasma insulin homeostatic model assessment
Time frame: MAD: Up to Day 30