FTIH of ECC5004 in Healthy and Diabetic Participants

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

Inclusion Criteria:Healthy male and female participants of non-childbearing potentialAge of 18 to 65 yearsBMI of 18.0 to 32.0 kg/m2Hemoglobin A1c ≤ 6.0%Female participants who are postmenopausal, confirmed by FSH test, or surgically sterile, confirmed by medical documentation, or agree to practice true abstinenceMale participants agree to use contraception, or agree to practice true abstinenceNo clinically significant findings in physical examination, 12-lead electrocardiogram (ECG), vital sign measurements, laboratory tests, or medical/psychiatric historyAble to understand and sign and date informed consentAdditional Inclusion Criteria for Part 2 (MAD)Diagnosed Type 2 Diabetes Mellitus of 18 to 70 years of age inclusiveType 2 Diabetes Mellitus with lifestyle modification only or with stable dose of metformin for ≥ 2 months prior to the study treatmentBMI 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/dLBlood pressure (BP) with or without medication: Systolic BP ≤ 160 mmHg, AND Diastolic BP ≤ 100 mmHgNot taking any active treatment regimenExclusion Criteria:Concomitant participation in any investigational study of any natureBlood 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 dosingUnable to refrain from taking any non-metformin anti-diabetic medication including insulin within ≥ 3 months prior to the study treatmentSerum calcitonin > 20 ng/LClinically relevant acute or chronic medical conditions or diseases of the cardiovascular, gastrointestinal, hepatic, renal, endocrine, pulmonary, neurologic, psychiatric, immune or dermatologic systemsDiagnosis of T1DM or secondary forms of diabetesIndividual or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia 2 (MEN2), or suspected MTCHistory of pancreatitisSignificant 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.