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

NCT ID: NCT06122714

Last Updated: 2024-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-07

Study Completion Date

2024-12-04

Brief Summary

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This study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple ascending doses of AZD4144 administered orally in healthy participants.

Detailed Description

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This is a Phase I, first time-in human (FTiH), randomised, single-blind, placebo-controlled, single ascending dose (SAD) and multiple ascending dose (MAD) sequential group study in healthy participants.

Part A consists of 3 parts:

Part A1 (healthy participants) Part A2 (healthy Japanese participants) and Part A3 (healthy Chinese participants)

Part B consists of 2 parts:

Part B1 (healthy participants) Part B2 (healthy Japanese participants)

Both Part A and Part B of the study will comprise of a screening period of maximum 28 days. The treatment period would last from Day -1 to Day 4 in Part A and from Day -1 to Day 15 in Part B of the study. A follow up visit will be performed on Day 10 + 3 days for Part A and on Day 20 + 3 days for Part B.

Each participant will participate for about 6 weeks in Part A of the study and for about 7 weeks in Part B of the study.

Conditions

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Healthy Participants

Keywords

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Single ascending dose (SAD) Multiple ascending dose (MAD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Part A1 (healthy participants) Cohort 1

Participants will receive one single ascending dose of AZD4144.

Group Type EXPERIMENTAL

AZD4144 Part A

Intervention Type DRUG

Part A: Participants will be administered a single oral dose on Day 1.

Part A1 (healthy participants) Cohort 2

Participants will receive one single ascending dose of AZD4144.

Group Type EXPERIMENTAL

AZD4144 Part A

Intervention Type DRUG

Part A: Participants will be administered a single oral dose on Day 1.

Part A1 (healthy participants) Cohort 3

Participants will receive one single ascending dose of AZD4144.

Group Type EXPERIMENTAL

AZD4144 Part A

Intervention Type DRUG

Part A: Participants will be administered a single oral dose on Day 1.

Part A1 (healthy participants) Cohort 4

Participants will receive one single ascending dose of AZD4144.

Group Type EXPERIMENTAL

AZD4144 Part A

Intervention Type DRUG

Part A: Participants will be administered a single oral dose on Day 1.

Part A1 (healthy participants) Cohort 5

Participants will receive one single ascending dose of AZD4144.

Group Type EXPERIMENTAL

AZD4144 Part A

Intervention Type DRUG

Part A: Participants will be administered a single oral dose on Day 1.

Part A1 (healthy participants) Cohort 6

Participants will receive one single ascending dose of AZD4144.

Group Type EXPERIMENTAL

AZD4144 Part A

Intervention Type DRUG

Part A: Participants will be administered a single oral dose on Day 1.

Part A1 (healthy participants) placebo

Participants will receive matching Placebo.

Group Type PLACEBO_COMPARATOR

Placebo Part A

Intervention Type DRUG

Part A: Participants will be administered a single oral dose of matching placebo on Day 1.

Part A2 (healthy Japanese participants) Cohort 1

Participants will receive one single ascending dose of AZD4144.

Group Type EXPERIMENTAL

AZD4144 Part A

Intervention Type DRUG

Part A: Participants will be administered a single oral dose on Day 1.

Part A2 (healthy Japanese participants) Cohort 2

Participants will receive one single ascending dose of AZD4144.

Group Type EXPERIMENTAL

AZD4144 Part A

Intervention Type DRUG

Part A: Participants will be administered a single oral dose on Day 1.

Part A2 (healthy Japanese participants) placebo

Participants will receive matching placebo.

Group Type PLACEBO_COMPARATOR

Placebo Part A

Intervention Type DRUG

Part A: Participants will be administered a single oral dose of matching placebo on Day 1.

Part A3 (healthy Chinese participants) Cohort 1

Participants will receive one single ascending dose of AZD4144.

Group Type EXPERIMENTAL

AZD4144 Part A

Intervention Type DRUG

Part A: Participants will be administered a single oral dose on Day 1.

Part A3 (healthy Chinese participants) placebo

Participants will receive matching placebo.

Group Type PLACEBO_COMPARATOR

Placebo Part A

Intervention Type DRUG

Part A: Participants will be administered a single oral dose of matching placebo on Day 1.

Part B1 (healthy participants) Cohort 1

Participants will receive one multiple ascending dose of AZD4144.

Group Type EXPERIMENTAL

AZD4144 Part B

Intervention Type DRUG

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.

Part B1 (healthy participants) Cohort 2

Participants will receive one multiple ascending dose of AZD4144.

Group Type EXPERIMENTAL

AZD4144 Part B

Intervention Type DRUG

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.

Part B1 (healthy participants) Cohort 3

Participants will receive one multiple ascending dose of AZD4144.

Group Type EXPERIMENTAL

AZD4144 Part B

Intervention Type DRUG

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.

Part B1 (healthy participants) placebo

Participants will receive matching placebo.

Group Type PLACEBO_COMPARATOR

Placebo Part B

Intervention Type DRUG

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.

Part B2 (healthy Japanese participants) Cohort 1

Participants will receive one multiple ascending dose of AZD4144.

Group Type EXPERIMENTAL

AZD4144 Part B

Intervention Type DRUG

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.

Part B2 (healthy Japanese participants) placebo

Participants will receive matching placebo.

Group Type PLACEBO_COMPARATOR

Placebo Part B

Intervention Type DRUG

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.

Interventions

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AZD4144 Part A

Part A: Participants will be administered a single oral dose on Day 1.

Intervention Type 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.

Intervention Type DRUG

Placebo Part A

Part A: Participants will be administered a single oral dose of matching placebo on Day 1.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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:

1. Previous bone marrow transplant
2. Non-leukocyte depleted whole blood transfusion within 120 days of the date of the genetic sample collection
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Parexel

INDUSTRY

Sponsor Role collaborator

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Glendale, California, United States

Site Status

Research Site

Brooklyn, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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D9440C00001

Identifier Type: -

Identifier Source: org_study_id