Assessment of the Safety, Tolerability and Pharmacodynamics After Administration of One Dose of AZD8601 to Male Patients With Type II Diabetes Mellitus (T2DM)

PHASE1CompletedINTERVENTIONAL
Enrollment

44

Participants

Timeline

Start Date

December 16, 2016

Primary Completion Date

August 4, 2017

Study Completion Date

January 8, 2018

Conditions
Male Subjects With Type II Diabetes (T2DM)
Interventions
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."

DRUG

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.

DRUG

Placebo+Placebo

Subjects are randomized to receive 2 placebo treatments.

Trial Locations (1)

14050

Research Site, Berlin

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Parexel

INDUSTRY

collaborator

Spandauer Damm 130

UNKNOWN

collaborator

14050

UNKNOWN

collaborator

Berlin, Germany

UNKNOWN

lead

AstraZeneca

INDUSTRY