A Clinical Trial in Healthy Volunteers and Patients With Mild Asthma to Investigate a New Medicine (AZD4604) for the Treatment of Asthma

Summary

This is a first in human clinical study. Part 1 of the clinical study will assess the safety and tolerability, as well as the single dose pharmacokinetics (PK), of inhaled AZD4604 in healthy volunteers (Part 1a, single ascending dose \[SAD\]). The single dose administration will be performed with dry powder inhaler (DPI) formulation of AZD4604. When at least 4 cohorts of the SAD part of the study have been completed, AZD4604 will be administered as a single intravenous (IV) or oral (PO) dose to 2 different cohorts of healthy volunteers (Part 1b). The main purpose is to compare the PK between IV, oral and inhaled administration to further characterize the PK properties of AZD4604 by the various administration routes. The results will be used to improve future study design and interpretation. In Part 2 (Multiple ascending dose \[MAD\]), AZD4604 will be administered at multiple doses (twice daily \[BID\], 7 days) to healthy volunteers. In Part 3, AZD4604 will be administered at multiple doses to patients with mild asthma at dose levels assessed in Part 2. The multiple-dose administration will be performed with DPI-formulated AZD4604.

Conditions

• Asthma

Interventions

DRUG

AZD4604 for inhalation via DPI

Healthy volunteers will receive AZD4604 administered with a DPI. The dose is expected to be administered between 10 to 45 minutes, depending upon dose. The dose will be administered after an overnight fast of at least 10 hours. Healthy volunteers will be allowed to drink water to prevent dehydration until 1 hour before dosing.

DRUG

Placebo for AZD4604 for inhalation via DPI

Part 1a: An additional cohort of healthy volunteers will receive a placebo administered with a DPI. Part 2: Healthy volunteers will receive placebo administered with a DPI. They will receive BID doses on Day 1 to Day 6, and a single dose will be administered on Day 7. Part 3: Patients will receive placebo administered with a DPI. They will receive BID doses on Day 1 to Day 9, and a single dose will be administered on Day 10.

DRUG

AZD4604 for IV administration

Healthy volunteers will receive a single IV dose of AZD4604 administered over 20 minutes. The dose will be administered after an overnight fast of at least 10 hours. Healthy volunteers will be allowed to drink water to prevent dehydration until 1 hour before dosing.

DRUG

AZD4604 for oral administration

Healthy volunteers will receive a single PO dose of AZD4604. The dose will be administered after an overnight fast of at least 10 hours. Healthy volunteers will be allowed to drink water to prevent dehydration until 1 hour before dosing.

DRUG

AZD4604 for inhalation via DPI

Patients with mild asthma will also receive AZD4604 administered with a DPI. Patients will receive BID doses on Day 1 to Day 9 (morning and evening with 12-hour intervals between doses), and a single morning dose will be administered on Day 10. On Day 1 and Day 10, the morning dose will be administered after an overnight fast of 10 hours. For all other doses, the dose will be administered after a 1-hour fast.

Sponsors & Collaborators

• AstraZeneca

  lead INDUSTRY

Principal Investigators

• Dr Pablo Forte Soto · Parexel Early Phase Clinical Unit (London)

• Rajkumar Chetty, Dr · Celerion

• Dave Singh · Medicines Evaluation Unit

• Jorg Taubel · Richmond Pharmacology Limited

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-07-08

Primary Completion

2023-01-24

Completion

2023-01-24

Countries

• United Kingdom

Study Locations