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:NCT06491550

EudraCT identifier:N/A

CTIS identifier:N/A

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

Study type

Interventional

Age

18 Years - 55 Years

Date

Study Start Date: 15 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 Sept 2024 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

• All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit.
• Females of childbearing potential must not be lactating and if heterosexually active must agree to use an approved method of highly effective contraception.
• Females of non-childbearing potential must be confirmed at the Screening Visit.
• Sexually active fertile male participants with partners of childbearing potential must adhere to the contraception methods.
• Have a BMI between 18 and 32 kg/m2 inclusive at both Screening and Admission and weigh at least 45 kg at Screening.
• For healthy Japanese cohorts (Part A2 and Part B2): healthy male and female participants are to be Japanese, defined as having both parents and 4 grandparents who are Japanese. This includes second and third generation participants of Japanese descent whose parents or grandparents are living in a country other than Japan.
• For healthy Chinese cohort (Part A3): healthy male and female Chinese participants for whom both parents and all grandparents are Chinese and not lived outside of China for more than 10 years.

Exclusion Criteria

• History of any clinically important disease or disorder or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
• Any clinically important illness, medical/surgical procedure, or trauma.
• Clinically significant serious active and chronic infections.
• Any history or evidence of TB (active or latent).
• Known history of primary immunodeficiency (congenital or acquired) or an underlying condition that predisposes to infection.
• Bacillus Calmette Guérin vaccine within one year prior to signing the ICF.
• Any abnormal laboratory values at the Screening Visit or on admission to the Clinical Unit.
• Any positive result on Screening for serum Hepatitis B surface antigen (HBsAg), anti-Hepatitis B core (HBc), hepatitis C antibody, or Human immunodeficiency virus (HIV).
• Any clinically important abnormalities in ECG.
• History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity.
• History of alcohol abuse or excessive intake of alcohol or current smokers or those who have smoked or used nicotine products.
• Use of drugs with enzyme inducing properties or of any prescribed or nonprescribed medication or of systemic hormonal contraceptives.
• Clinical signs and symptoms consistent with COVID-19.

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Arms	Assigned Interventions
Experimental: Part A1-Cohort 1 Participants will receive one single ascending dose of AZD4144.	Drug: AZD4144- Part A Part A: Participants will be administered a single dose of AZD4144 on Day 1 via Intravenous (IV) infusion.
Experimental: Part A1- Cohort 2 Participants will receive one single ascending dose of AZD4144.	Drug: AZD4144- Part A Part A: Participants will be administered a single dose of AZD4144 on Day 1 via Intravenous (IV) infusion.
Experimental: Part A1-Cohort 3 Participants will receive one single ascending dose of AZD4144.	Drug: AZD4144- Part A Part A: Participants will be administered a single dose of AZD4144 on Day 1 via Intravenous (IV) infusion.
Experimental: Part A2-Japanese cohort 1 Participants will receive one single ascending dose of AZD4144.	Drug: AZD4144- Part A Part A: Participants will be administered a single dose of AZD4144 on Day 1 via Intravenous (IV) infusion.
Experimental: Part A2: Japanese Cohort 2 Participants will receive one single ascending dose of AZD4144.	Drug: AZD4144- Part A Part A: Participants will be administered a single dose of AZD4144 on Day 1 via Intravenous (IV) infusion.
Experimental: Part A3-Chinese Cohort Participants will receive one single ascending dose of AZD4144.	Drug: AZD4144- Part A Part A: Participants will be administered a single dose of AZD4144 on Day 1 via Intravenous (IV) infusion.
Experimental: Part B1- Cohort 1 Participants will receive multiple ascending doses of AZD4144.	Drug: AZD4144- Part B Part B: Participants will be administered a single dose of AZD4144 on Day 1 and Day 12 via IV infusion. Participants will be administered multiple doses of AZD4144 from Day 4 to Day 11 via IV infusion.
Experimental: Part B1- Cohort 2 Participants will receive multiple ascending doses of AZD4144.	Drug: AZD4144- Part B Part B: Participants will be administered a single dose of AZD4144 on Day 1 and Day 12 via IV infusion. Participants will be administered multiple doses of AZD4144 from Day 4 to Day 11 via IV infusion.
Experimental: Part B1- Cohort 3 Participants will receive multiple ascending doses of AZD4144.	Drug: AZD4144- Part B Part B: Participants will be administered a single dose of AZD4144 on Day 1 and Day 12 via IV infusion. Participants will be administered multiple doses of AZD4144 from Day 4 to Day 11 via IV infusion.
Experimental: Part B2- Japanese Cohort Participants will receive multiple ascending doses of AZD4144.	Drug: AZD4144- Part B Part B: Participants will be administered a single dose of AZD4144 on Day 1 and Day 12 via IV infusion. Participants will be administered multiple doses of AZD4144 from Day 4 to Day 11 via IV infusion.
Experimental: Part C Cohort- Treatment C1 Participants will receive Rosuvastatin.	Drug: Rosuvastatin- Part C Participants will be administered a single oral dose of 10 mg Rosuvastatin.
Experimental: Part C cohort- Treatment C2 Participants will receive rosuvastatin and AZD4144.	Drug: Rosuvastatin and AZD4144 Part C Participants will be administered a single oral dose of Rosuvastatin and a single dose of AZD4144 via IV infusion.
Placebo Comparator: Part A1- Placebo Participants will receive matching placebo.	Drug: Placebo- Part A Part A: Participants will be administered a single dose of placebo on Day 1 via IV infusion.
Placebo Comparator: Part A2- Placebo Participants will receive matching placebo.	Drug: Placebo- Part A Part A: Participants will be administered a single dose of placebo on Day 1 via IV infusion.
Placebo Comparator: Part A3- Placebo Participants will receive matching Placebo.	Drug: Placebo- Part A Part A: Participants will be administered a single dose of placebo on Day 1 via IV infusion.
Placebo Comparator: Part B1- Placebo Participants will receive matching Placebo.	Drug: Placebo- Part B Part B: Participants will be administered a single dose of placebo on Day 1 and Day 12via IV infusion. Participants will be administered multiple doses of placebo from Day 4 to Day 11 via IV infusion.
Placebo Comparator: Part B2- Placebo Participants will receive matching Placebo.	Drug: Placebo- Part B Part B: Participants will be administered a single dose of placebo on Day 1 and Day 12via IV infusion. Participants will be administered multiple doses of placebo from Day 4 to Day 11 via IV infusion.

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]