AZD7798 Safety, Tolerability, and Pharmacokinetics after a single ascending and repeat dose administrations to healthy subjects, and patients with Crohn's disease

Study identifier:D9690C00001

ClinicalTrials.gov identifier:NCT05452304

EudraCT identifier:2022-001438-12

CTIS identifier:N/A

Recruitment Complete

Official Title

A Phase 1 Randomised, Double-Blind, Placebo-Controlled 3 Part Study to assess the Safety, Tolerability and Pharmacokinetics of AZD7798 following Single Ascending Dose Administration and Repeat Dose Administration in Healthy Subjects (including Japanese and Chinese Subjects), and Patients with Crohn's Disease

Medical condition

Healthy subjects, Crohns disease

Phase

Phase 1

Healthy volunteers

Yes

Study drug

-

Sex

All

Actual Enrollment

106

Study type

Interventional

Age

18 Years - 60 Years

Date

Study Start Date: 12 Jul 2022
Estimated Primary Completion Date: 07 Nov 2024
Estimated Study Completion Date: 15 Aug 2025

Study design

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

Verification:

Verified 01 Aug 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

PAREXEL

Inclusion and exclusion criteria