A Phase 2a Dose-Finding Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NLY01, a PEGylated Exenatide, when Administered as a Single Dose in Subjects with Type 2 Diabetes

euraly, Inc.0 个研究点目标入组 18 人开始时间: 2019年8月12日最近更新: 2021年11月29日

适应症

试验速览

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•- Signed and dated informed consent obtained before any trial-related activities
•- Male or female subject with type 2 diabetes mellitus for at least one year
•- Age between 18 and 65 years, both inclusive
•- Treated with metformin for at least 3 months either alone or in combination with a second oral antidiabetic agent.
•- Willing to continue treatment with metformin at the same dose and frequency until Day 30 and (if applicable) to pause any treatment with a second oral antidiabetic agent from at least 7 days before dosing and until Day 35
•- Body Mass Index (BMI) 22.0 to 35.0 kg/m^2, inclusive
•- HbA1c at screening between 7.0% and 9.0% (inclusive) for subjects treated with metformin alone or HbA1c at screening between 6.5% and 8.5% (inclusive) for subjects treated with metformin in combination with a second oral antidiabetic Agent
•- Considered generally healthy (apart from type 2 diabetes mellitus) upon completion of medical history and screening safety assessments, as judged by the Investigator
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 17
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 1

•- Known or suspected hypersensitivity to the IMP or related products
•- Known contra-indication to exenatide
•- Established CV Disease
•- History of severe hypoglycaemia with seizure, coma or requiring assistance of another person during the past 6 months
•- Treated with insulin, GLP-1 receptor agonisits or oral antidiabetic drugs (OADs) other than those specified in the inclusion criterion 4 within 3 months prior to screening
•- Any prior exposure to an exenatide-based product (Byetta® and Bydureon®)
•- Men with non-pregnant partner(s) of childbearing potential not willing to use male contraception (condom) in addition to a highly effective contraceptive method until 90 days after dosing
•- Men with pregnant partner not willing to use male contraception (condom) until 90 days after dosing, in order to avoid exposure of the embryo/fetus to seminal fluid

发起方

euraly, Inc.