A first-in-human study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD2373 after single dose administration in healthy male subjects of African ancestry.

Study identifier:D6800C00001

ClinicalTrials.gov identifier:NCT04269031

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase I, First-in-Human, Randomized, Single-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD2373 following Single Ascending Dose Administrations to Healthy Male Subjects of African Ancestry

Medical condition

Healthy Volunteers

Phase

Phase 1

Healthy volunteers

Yes

Study drug

AZD2373 subcutaneous injection, AZD2373 subcutaneous injection, AZD2373 subcutaneous injection, AZD2373 subcutaneous injection, AZD2373 subcutaneous injection, AZD2373 subcutaneous injection, Placebo, Placebo, Placebo, Placebo, Placebo, Placebo

Sex

Male

Actual enrollment

30

Study type

Interventional

Age

18 Years - 55 Years

Date

Study Start Date: 13 Feb 2020
Primary Completion Date: 08 Jul 2021
Study Completion Date: 08 Jul 2021

Study design

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

Verification:

Verified 01 Dec 2022 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

Parexel International

Inclusion and exclusion criteria