Type 2 Diabetes Mellitus
Conditions
Brief summary
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
Detailed description
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
Interventions
DRUGPlacebo
Matching Placebo will be administered as oral tablet. Matching Placebo will be given orally during each dosing day.
DRUGECC5004
ECC5004 will be administered as oral tablet(s) during each dosing day.
Sponsors
Eccogene
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male and female participants of non-childbearing potential * Age of 18 to 65 years * BMI of 18.0 to 32.0 kg/m2 * Hemoglobin A1c ≤ 6.0% * Female participants who are postmenopausal, confirmed by FSH test, or surgically sterile, confirmed by medical documentation, or agree to practice true abstinence * Male participants agree to use contraception, or agree to practice true abstinence * No clinically significant findings in physical examination, 12-lead electrocardiogram (ECG), vital sign measurements, laboratory tests, or medical/psychiatric history * Able to understand and sign and date informed consent Additional Inclusion Criteria for Part 2 (MAD) * Diagnosed Type 2 Diabetes Mellitus of 18 to 70 years of age inclusive * Type 2 Diabetes Mellitus with lifestyle modification only or with stable dose of metformin for ≥ 2 months prior to the study treatment * BMI of 24.0 to 40.0 kg/m2 with a minimum body weight of 50.0 kg (110 lbs) * HbA1c ≥ 7.0% and ≤ 10.5%, and fasting plasma glucose ≤ 270 mg/dL * Blood pressure (BP) with or without medication: Systolic BP ≤ 160 mmHg, AND Diastolic BP ≤ 100 mmHg * Not taking any active treatment regimen
Exclusion criteria
* Concomitant participation in any investigational study of any nature * Blood loss of non-physiological reasons ≥ 200 ml (i.e. trauma, blood collection, blood donation) within 2 months prior to the first dose of study drug, or plan to donate blood during this trial and within 1 month after the last dosing * Unable to refrain from taking any non-metformin anti-diabetic medication including insulin within ≥ 3 months prior to the study treatment * Serum calcitonin \> 20 ng/L * Clinically relevant acute or chronic medical conditions or diseases of the cardiovascular, gastrointestinal, hepatic, renal, endocrine, pulmonary, neurologic, psychiatric, immune or dermatologic systems * Diagnosis of T1DM or secondary forms of diabetes * Individual or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia 2 (MEN2), or suspected MTC * History of pancreatitis * Significant allergic reaction to active ingredients or excipients of the study drug. * Any clinically significant abnormal findings in the participant's physical examination, laboratory tests, pregnancy test, urine drug screen, alcohol test, or medical history which in the opinion of the Investigator would prevent the participants from participating in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events, with abnormal laboratory test results, abnormal ECGs, abnormal vital signs, and abnormal physical examinations | SAD: Up to Day 8 and MAD: Up to Day 35 | Safety Assessment evaluated through adverse events, laboratory evaluations, vital signs, ECGs, and physical examination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic Parameters: AUC0-tlast | SAD: Up to Day 3 | AUC from time 0 to the time of last quantifiable non-zero concentration |
| Pharmacokinetic Parameters: AUC0-tau | MAD: Up to Day 30 | AUC over a dosing interval from time 0 to time of last quantifiable concentration |
| Pharmacokinetic Parameters: AUC0-infinity | SAD: Up to Day 3 | AUC from time 0 extrapolated to infinity |
| Pharmacokinetic Parameters: Cmax | SAD: Up to Day 3 and MAD: Up to Day 30 | Maximum observed plasma concentration |
| Pharmacokinetic Parameters: C24 | SAD: Up to Day 3 and MAD: Up to Day 30 | Observed concentration at 24 hours post dose |
| Pharmacokinetic Parameters: Ctau | MAD: Up to Day 30 | Observed concentration at the end of the dosing interval |
| Pharmacokinetic Parameters: tmax | SAD: Up to Day 3 and MAD: Up to Day 30 | Time of the maximum observed plasma concentration |
| Pharmacokinetic Parameters: tlag | SAD: Up to Day 3 and MAD: Up to Day 30 | Lag time (time delay between dosing and first observed plasma concentration) |
| Pharmacokinetic Parameters: t1/2 | SAD: Up to Day 3 and MAD: Up to Day 30 | Apparent terminal elimination half-life |
| Pharmacokinetic Parameters: Clast | SAD: Up to Day 3 | Last measurable non-zero concentration |
| Pharmacokinetic Parameters: AUC0-24 | SAD: Up to Day 3 and MAD: Up to Day 30 | AUC from time 0 to 24 hour dosing interval |
| Pharmacokinetic Parameters: CL/F | SAD: Up to Day 3 and MAD: Up to Day 30 | Apparent Clearance |
| Pharmacodynamic Parameters: AUC0-4 for glucose | MAD: Up to Day 30 | AUC from time 0 to 4 hour dosing interval |
| Pharmacodynamic Parameters: AUC0-4 for insulin | MAD: Up to Day 30 | AUC from time 0 to 4 hour dosing interval |
| Pharmacodynamic Parameters: AUC0-4 for glucagon | MAD: Up to Day 30 | AUC from time 0 to 4 hour dosing interval |
| Pharmacodynamic Parameters: AUC0-4 for C-peptide | MAD: Up to Day 30 | AUC from time 0 to 4 hour dosing interval |
| Pharmacodynamic Parameters: Fasting plasma glucose | MAD: Up to Day 30 | Change from baseline |
| Pharmacodynamic Parameters: Mean daily glucose | MAD: Up to Day 30 | Change from baseline |
| Pharmacodynamic Parameters: Body Weight and Waist Circumference | MAD: Up to Day 30 | Change from baseline |
| Pharmacodynamic Parameters: Fasting plasma glucose homeostatic model assessment | MAD: Up to Day 30 | Fasting plasma glucose homeostatic model assessment |
| Pharmacodynamic Parameters: Fasting plasma insulin homeostatic model assessment | MAD: Up to Day 30 | Fasting plasma insulin homeostatic model assessment |
| Pharmacokinetic Parameters: tlast | SAD: Up to Day 3 | Time of last measurable non-zero concentration |
Countries
United States
Outcome results
None listed