A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD4144 Following Single and Multiple Ascending Doses via Oral Administration to Healthy Participants

Study identifier:D9440C00001

ClinicalTrials.gov identifier:NCT06122714

EudraCT identifier:N/A

CTIS identifier:N/A

Recruiting

Official Title

A Phase I Randomised, 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 Oral Administration to Healthy Participants

Medical condition

Healthy Participants

Phase

Phase 1

Healthy volunteers

Yes

Study drug

AZD4144 Part A, AZD4144 Part B, Placebo Part A, Placebo Part B

Sex

All

Estimated Enrollment

104

Study type

Interventional

Age

18 Years - 55 Years

Date

Study Start Date: 07 Nov 2023

Estimated Primary Completion Date: 09 Aug 2024

Estimated Study Completion Date: 09 Aug 2024

Study design

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

Verification:

Verified 01 Feb 2024 by AstraZeneca

Collaborators

PAREXEL

Inclusion and exclusion criteria

Inclusion Criteria

- Females must have a negative pregnancy test, must not be lactating and must be of non-childbearing potential.
- 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 (of non-childbearing potential) participants are to be Japanese, defined as having both parents and four grandparents who are Japanese. This included 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 (of non-childbearing potential) 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 which, in the opinion of the Investigator, may either put the participant at risk because of participation in the study.
- History 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.
- Bacillus Calmette-Guérin vaccine within one year prior to signing the ICF.
- Any abnormal laboratory values at the Screening Visit.
- 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 cardiac abnormalities.
- History of alcohol abuse or drug abuse.
- Current smokers or those who have smoked or used nicotine products.
- History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity.
- Clinical signs and symptoms consistent with COVID-19.
- In addition, any of the following is regarded as a criterion for exclusion from the genetic research:
(a) Previous bone marrow transplant
(b) Non-leukocyte depleted whole blood transfusion within 120 days of the date of the genetic sample collection

Sort by status

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Arms	Assigned Interventions
Experimental: Part A1 (healthy participants) Cohort 1 Participants will receive one single ascending dose of AZD4144.	Drug: AZD4144 Part A Part A: Participants will be administered a single oral dose on Day 1.
Experimental: Part A1 (healthy participants) Cohort 2 Participants will receive one single ascending dose of AZD4144.	Drug: AZD4144 Part A Part A: Participants will be administered a single oral dose on Day 1.
Experimental: Part A1 (healthy participants) Cohort 3 Participants will receive one single ascending dose of AZD4144.	Drug: AZD4144 Part A Part A: Participants will be administered a single oral dose on Day 1.
Experimental: Part A1 (healthy participants) Cohort 4 Participants will receive one single ascending dose of AZD4144.	Drug: AZD4144 Part A Part A: Participants will be administered a single oral dose on Day 1.
Experimental: Part A1 (healthy participants) Cohort 5 Participants will receive one single ascending dose of AZD4144.	Drug: AZD4144 Part A Part A: Participants will be administered a single oral dose on Day 1.
Experimental: Part A1 (healthy participants) Cohort 6 Participants will receive one single ascending dose of AZD4144.	Drug: AZD4144 Part A Part A: Participants will be administered a single oral dose on Day 1.
Placebo Comparator: Part A1 (healthy participants) placebo Participants will receive matching Placebo.	Drug: Placebo Part A Part A: Participants will be administered a single oral dose of matching placebo on Day 1.
Experimental: Part A2 (healthy Japanese participants) Cohort 1 Participants will receive one single ascending dose of AZD4144.	Drug: AZD4144 Part A Part A: Participants will be administered a single oral dose on Day 1.
Experimental: Part A2 (healthy Japanese participants) Cohort 2 Participants will receive one single ascending dose of AZD4144.	Drug: AZD4144 Part A Part A: Participants will be administered a single oral dose on Day 1.
Placebo Comparator: Part A2 (healthy Japanese participants) placebo Participants will receive matching placebo.	Drug: Placebo Part A Part A: Participants will be administered a single oral dose of matching placebo on Day 1.
Experimental: Part A3 (healthy Chinese participants) Cohort 1 Participants will receive one single ascending dose of AZD4144.	Drug: AZD4144 Part A Part A: Participants will be administered a single oral dose on Day 1.
Placebo Comparator: Part A3 (healthy Chinese participants) placebo Participants will receive matching placebo.	Drug: Placebo Part A Part A: Participants will be administered a single oral dose of matching placebo on Day 1.
Experimental: Part B1 (healthy participants) Cohort 1 Participants will receive one multiple ascending dose of AZD4144.	Drug: AZD4144 Part B Part B: Participants will be administered a single dose on Day 1, and repeated dosing will commence from Day 4 until Day 11 (inclusive) and a single dose on Day 12.
Experimental: Part B1 (healthy participants) Cohort 2 Participants will receive one multiple ascending dose of AZD4144.	Drug: AZD4144 Part B Part B: Participants will be administered a single dose on Day 1, and repeated dosing will commence from Day 4 until Day 11 (inclusive) and a single dose on Day 12.
Experimental: Part B1 (healthy participants) Cohort 3 Participants will receive one multiple ascending dose of AZD4144.	Drug: AZD4144 Part B Part B: Participants will be administered a single dose on Day 1, and repeated dosing will commence from Day 4 until Day 11 (inclusive) and a single dose on Day 12.
Placebo Comparator: Part B1 (healthy participants) placebo Participants will receive matching placebo.	Drug: Placebo Part B Part B: Participants will be administered a single dose of matching placebo on Day 1, and repeated dosing will commence from Day 4 until Day 11 (inclusive) and a single dose on Day 12.
Experimental: Part B2 (healthy Japanese participants) Cohort 1 Participants will receive one multiple ascending dose of AZD4144.	Drug: AZD4144 Part B Part B: Participants will be administered a single dose on Day 1, and repeated dosing will commence from Day 4 until Day 11 (inclusive) and a single dose on Day 12.
Placebo Comparator: Part B2 (healthy Japanese participants) placebo Participants will receive matching placebo.	Drug: Placebo Part B Part B: Participants will be administered a single dose of matching placebo on Day 1, and repeated dosing will commence from Day 4 until Day 11 (inclusive) and a single dose on Day 12.

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]