A Randomised, Open-Label Study to Evaluate the Relative and Absolute Bioavailability of Cotadutide in Healthy Subjects

Study identifier:D5671C00009

ClinicalTrials.gov identifier:NCT05294458

EudraCT identifier:2021-005442-15

CTIS identifier:N/A

Study Complete

Official Title

A Single Part, Three-Way Crossover, Randomised, Open-Label Study Designed to Evaluate the Relative and Absolute Bioavailability Following a Single Subcutaneous Injection of a Novel High Concentration Subcutaneous Formulation of Cotadutide Against a Low Concentration Subcutaneous Formulation and Intravenous (IV) Formulation for Reference, in Healthy Subjects

Medical condition

non-alcoholic steatohepatitis

Phase

Phase 1

Healthy volunteers

Yes

Study drug

cotadutide solution for injection

Sex

All

Actual Enrollment

10

Study type

Interventional

Age

18 Years - 55 Years

Date

Study Start Date: 28 Mar 2022
Primary Completion Date: 12 Sept 2022
Study Completion Date: 12 Sept 2022

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Sept 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

Quotient Sciences Ltd

Inclusion and exclusion criteria