A Phase I, Randomized, Single-Blind, Placebo Controlled Study to Assess the Safety, Tolerability and Pharmacodynamics Of AZD8601 After Single Dose Administration to Male Patients With Type II Diabetes Mellitus (T2DM)
Male subjects with type II diabetes (T2DM)
AZD8601+Placebo (SAD), AZD8601+Placebo, Placebo+Placebo
18 Years - 65 Years
Endpoint Classification: Safety
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Verified 01 Jan 2020 by AstraZeneca
PAREXEL International GmbH, Spandauer Damm 130, 14050, Berlin, Germany
No locations available
|Experimental: Part A|
Three cohorts with 9 subjects and each cohort received 2 treatments (AZD8601+Placebo/ Placebo+Placebo)
Drug: AZD8601+Placebo (SAD)
Six subjects are randomized to receive one treatment of AZD8601 and one treatment of Placebo. Single ascending dose (SAD) with a sequential cohort design and three dose levels of AZD8601 are planned to be investigated. Subjects will receive 0.004 mg per injection of AZD8601/placebo with a total proposed dose of 0.024 mg.
Subjects are randomized to receive 2 placebo treatments.
|Experimental: Part B|
Subjects received 2 treatments (AZD8601+Placebo)
Subjects will receive dose with sufficient vascular endothelial growth factor (VEGF)-A protein production and a good safety profile as determined in Part A and the total dose per patient will not exceed the maximum dose given in Part A.