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

NCT02935712 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2020-01-18

No results posted yet for this study

Summary

This study will be a phase I, first time in human (FiH), randomized, single-blind, placebo-controlled, SAD study in male patients with T2DM, performed at a single study center. The study will consist of 2 parts, (A and B) up to 60 male patients with T2DM aged 18 to 65 years will be included

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.

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • Spandauer Damm 130

    collaborator UNKNOWN

  • 14050

    collaborator UNKNOWN

  • Berlin, Germany

    collaborator UNKNOWN

  • AstraZeneca

    lead INDUSTRY

Principal Investigators

  • Rainard Fuhr, Dr. med. · Early Phase Clinical Unit, PAREXEL International GmbH, Berlin

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-16
Primary Completion
2017-08-04
Completion
2018-01-08

Countries

  • Germany

Study Locations

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Entities

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02935712 on ClinicalTrials.gov