A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Inhaled AZD4604 in Healthy Japanese and Chinese Participants.

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: Placebo; Drug: AZD4604

Study type: Interventional

Funder types: Industry

Identifiers

NCT06519968

D8210C00002

Details and patient eligibility

About

The purpose of this study is to investigate the safety, tolerability, and pharmacokinetics (PK) of AZD4604 when administered as single or multiple inhaled doses to healthy Japanese and Chinese participants.

Full description

This study will comprise of two parts: Part 1 and Part 2

Part 1 will investigate the safety, tolerability, and PK of inhaled AZD4604 following single ascending and multiple doses in healthy Japanese participants.

Part 1a will include three single ascending dose (SAD) cohorts and Part 1b will include one multiple dose cohort.

Part 2 will investigate the safety, tolerability, and PK of inhaled AZD4604 following single ascending and multiple doses in healthy Chinese participants.

Part 2a will include two SAD cohort and Part 2b will include one multiple dose cohort.

Part 1a and Part 2a will comprise of:

1. A Screening Visit within 28 days before dosing.
2. A treatment period (Day 1 to Day 7)
3. A final assessment on Day 7

Part 1b and Part 2b will comprise of:

1. A Screening Visit within 28 days before dosing.
2. A treatment period (Day 1 to Day 13)
3. A final assessment on Day 13

Enrollment: 56 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Japanese participants who are born in Japan, has 2 Japanese biological parents, 4 Japanese grandparents as confirmed by the interview and has lived outside Japan for less than 10 years at the time of screening.
• Chinese participants who are born in China, has 2 Chinese biological parents, 4 Chinese grandparents as confirmed by the interview and has lived outside China for less than 10 years at the time of screening.
• Have body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 45 kg.
• Healthy participants must have a Forced Expiratory Volume at first breath (FEV1) ≥ 80% of the predicted value in accordance with American Thoracic Society (ATS)/European Respiratory Society (ERS) criteria at the Screening and admission visits.
• Female participants must have a negative pregnancy test.

Exclusion criteria

• History or presence of clinically important disease which may put participant at risk because of participation in study.
• Participant has an increased risk of infection.
• History of malignancy other than superficial basal cell carcinoma, having a first degree relative with lung cancer or disease history suggesting abnormal immune function.
• Has received any vaccine 30 days prior to first dose.
• Has a body temperature of > 37.7°C on Day -1.
• 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 within 4 weeks of the first administration of study intervention.
• Known or suspected history of drug abuse, alcohol abuse or excessive intake of alcohol.
• Current smokers or those who have smoked or used nicotine products (including e-cigarettes, vaping, and nicotine replacement therapy) within the previous 6 months or has a smoking history of > 5 pack-years.
• History of a serious or severe adverse reaction to AZD4604 or any of its additive constituents.
• History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity or history of hypersensitivity to drugs with a similar chemical structure or class to AZD4604.
• Plasma donation within 1 month of the Screening Visit or any blood donation/blood loss> 500 mL during the 3 months prior to the Screening Visit.
• Any clinically important abnormalities in rhythm, conduction or morphology of the resting electrocardiogram (ECG) and any clinically important abnormalities in the 12-lead safety ECG.
• Female participants who are planning a pregnancy during the study period or within 1 month after the last dose of study intervention.
• Abnormal vital signs at the Screening Visit, after 5 minutes supine rest.
• History of any significant respiratory disorders such as asthma (a history of childhood asthma without symptoms or treatment after the age of 10 years is allowable), chronic obstructive pulmonary disease, or idiopathic pulmonary fibrosis.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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56 participants in 11 patient groups, including a placebo group

Part 1a: AZD4604 (Dose 1) SAD

Experimental group

Description:

Japanese participants will receive single dose of AZD4604 (Dose 1) via inhalation on Day 1.

Treatment:

Drug: AZD4604

Part 1a: AZD4604 (Dose 2) SAD

Experimental group

Description:

Japanese participants will receive single dose of AZD4604 (Dose 2) via inhalation on Day 1.

Treatment:

Drug: AZD4604

Part 1a: AZD4604 (Dose 3) SAD

Experimental group

Description:

Japanese participants will receive single dose of AZD4604 (Dose 3) via inhalation on Day 1.

Treatment:

Drug: AZD4604

Part 1a: Placebo

Placebo Comparator group

Description:

Japanese participants will receive single dose of matching placebo to AZD4604 on Day 1.

Treatment:

Drug: Placebo

Part 1b: AZD4604 (Dose 4) Multiple dose cohort

Experimental group

Description:

Japanese participants will receive AZD4604 (Dose 4) via inhalation twice daily (BID) from Day 1 to Day 6 and a single dose on Day 7.

Treatment:

Drug: AZD4604

Part 1b: Placebo

Placebo Comparator group

Description:

Japanese participants will receive matching placebo to AZD4604 BID from day 1 to day 6 and a single dose of placebo on Day 7.

Treatment:

Drug: Placebo

Part 2a: AZD4604 (Dose 1) SAD

Experimental group

Description:

Chinese participants will receive single dose of AZD4604 (Dose 1) via inhalation on Day 1.

Treatment:

Drug: AZD4604

Part 2a: AZD4604 (Dose 3) SAD

Experimental group

Description:

Chinese participants will receive single dose of AZD4604 (Dose 3) via inhalation on Day 1.

Treatment:

Drug: AZD4604

Part 2a: Placebo

Placebo Comparator group

Description:

Chinese participants will receive single dose of matching placebo to AZD4604 on Day 1.

Treatment:

Drug: Placebo

Part 2 b: AZD4604 (Dose 4) Multiple dose cohort

Experimental group

Description:

Chinese participants will receive AZD4604 (Dose 4) via inhalation BID from Day 1 to Day 6 and a single dose on Day 7.

Treatment:

Drug: AZD4604

Part 2b: Placebo

Placebo Comparator group

Description:

Chinese participants will receive placebo via inhalation BID from Day 1 to Day 6 and a single dose on Day 7.

Treatment:

Drug: Placebo