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

NCT06519968 | Completed Phase 1 DMC

• 1 other identifier: D8210C00002
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Participants

Keywords

Ascending doses; Multiple doses; JAK1 inhibitor; Chinese; Japanese

Outcome Measures

Primary Outcomes (1)

• Number of participants with adverse event (AEs)

  To assess the safety and tolerability of AZD4604 following inhaled administration of AZD4604 as single ascending doses (Parts 1a and 2a), and multiple doses (Parts 1b and 2b).

  From Day -28 to 5 weeks (Parts 1a and 2a); Day -28 to 6 weeks (Parts 1b and 2b)

Secondary Outcomes (17)

• Maximum observed plasma (peak) drug concentration (Cmax)

  From Day 1 to Day 7 (Parts 1a and 2a); From Day 1 to Day 13 (Parts 1b and 2b)

• Time to reach peak or maximum observed concentration following drug administration (tmax)

  From Day 1 to Day 7 (Parts 1a and 2a); From Day 1 to Day 13 (Parts 1b and 2b)

• Terminal elimination rate constant (λz)

  From Day 1 to Day 7 (Parts 1a and 2a); From Day 1 to Day 13 (Parts 1b and 2b)

• Half-life associated with terminal slope of a semi-logarithmic concentration time curve (t½λz)

  From Day 1 to Day 7 (Parts 1a and 2a); From Day 1 to Day 13 (Parts 1b and 2b)

• Partial area under concentration-time curve from time 0 to 12 hours (AUC [0-12])

  From Day 1 to Day 7 (Parts 1a and 2a); On Day 1 (Parts 1b and 2b)

Study Arms (11)

Part 1a: AZD4604 (Dose 1) SAD

EXPERIMENTAL

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

Drug: AZD4604

Part 1a: AZD4604 (Dose 2) SAD

EXPERIMENTAL

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

Drug: AZD4604

Part 1a: AZD4604 (Dose 3) SAD

EXPERIMENTAL

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

Drug: AZD4604

Part 1a: Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

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

EXPERIMENTAL

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.

Drug: AZD4604

Part 1b: Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Part 2a: AZD4604 (Dose 1) SAD

EXPERIMENTAL

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

Drug: AZD4604

Part 2a: AZD4604 (Dose 3) SAD

EXPERIMENTAL

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

Drug: AZD4604

Part 2a: Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

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

EXPERIMENTAL

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

Drug: AZD4604

Part 2b: Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

AZD4604 DRUG

AZD4604 will be administered as Dry Powder Inhalation (DPI).

Part 1a: AZD4604 (Dose 1) SAD; Part 1a: AZD4604 (Dose 2) SAD; Part 1a: AZD4604 (Dose 3) SAD; Part 1b: AZD4604 (Dose 4) Multiple dose cohort; Part 2 b: AZD4604 (Dose 4) Multiple dose cohort; Part 2a: AZD4604 (Dose 1) SAD; Part 2a: AZD4604 (Dose 3) SAD

Placebo DRUG

Placebo will be administered as DPI.

Part 1a: Placebo; Part 1b: Placebo; Part 2a: Placebo; Part 2b: Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead
• Parexel: collaborator

Study Sites (1)

Research Site

Harrow, HA1 3UJ, United Kingdom

Location

Related Links

• D8210C00002\_CSR Synopsis\_Redacted
• Astrazenecaclinicaltrials.com-study results

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2024
• First Posted: July 25, 2024
• Study Start: July 15, 2024
• Primary Completion: December 27, 2024
• Study Completion: December 27, 2024
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

GB (1)