FTIH of ECC5004 in Healthy and Diabetic Participants
Type 2 Diabetes Mellitus
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus
Eligibility Criteria
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.
Sites / Locations
- Eccogene Investigational SiteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Placebo Comparator
Experimental
Placebo Comparator
Experimental
SAD Cohorts 1 to 2: Participants receiving Placebo
SAD Cohorts 1 to 2: Participants receiving ECC5004
MAD Cohorts 1 to 4: Participants receiving Placebo
MAD Cohorts 1 to 4: Participants receiving ECC5004
Participants in each SAD cohort will be randomized to receive placebo.
Participants in each SAD cohort will be randomized to receive up to 4 escalating doses of ECC5004 ranging from 1 mg to 300 mg.
Participants will be randomized to receive a once-daily dose of placebo for 28 days.
Participants will be randomized to receive a once-daily dose of 1 of 4 escalating doses of ECC5004 ranging from 10 mg to 150 mg for 28 days.