A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD4144 as well as the Impact of AZD4144 on the Pharmacokinetics of Rosuvastatin in Healthy Participants

Study identifier:D9440C00002

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Will Be Recruiting

Official Title

A Phase I Randomized, Single-blind, Placebo-controlled, and Sequential Group Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD4144 Following Single and Multiple Ascending Doses via Intravenous Administration, and an Open-label, 2-Period, 2-Sequence, Cross-over Study to Assess the Effects of Intravenous AZD4144 on Rosuvastatin Pharmacokinetics in Healthy Participants

Medical condition

Healthy Participants

Phase

Phase 1

Healthy volunteers

Yes

Study drug

AZD4144- Part A, Placebo- Part A, AZD4144- Part B, Placebo- Part B, Rosuvastatin- Part C, Rosuvastatin and AZD4144 Part C

Sex

All

Estimated Enrollment

92

Study type

Interventional

Age

18 Years - 55 Years

Date

Study Start Date: 16 Jul 2024
Estimated Primary Completion Date: 11 Apr 2025
Estimated Study Completion Date: 11 Apr 2025

Study design

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

Verification:

Verified 01 Jun 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria