A First in Human, Placebo-Controlled, Randomized, Double-Blind, Rising Single Dose Study of ADV-1002401 to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Healthy, Adult Volunteers and Adult Type-II Diabetic Volunteers - Phase 01 Study

Advinus Therapeutics Pvt Ltd0 个研究点目标入组 46 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•Male subjects aged between 18 and 55 years (including both) with BMI between 18 to 25 kg/m2 (including both) with normal health as determined by personal medical history, clinical examination, 12 lead ECG, X-ray and laboratory examinations within the clinically acceptable normal range.
•Male diabetics aged between 18 and 60 years (including both) with BMI between 20 to 32 kg/m2 (including both).
•Subjects with fasting blood glucose of 125 to 200 mg/dL while on current medication (metformin or sulfonylurea) / Drug naÃ¯ve T2DM subjects with fasting plasma glucose of 125 to 200 mg/dL.
•Subjects with HbA1c greater than or equal to 7.5%, and less than or equal to 10.5%.

•Exclusion Criteria:
•History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
•History or presence of significant gastric and/or duodenal ulceration
•History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumour

发起方

Advinus Therapeutics Pvt Ltd