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.
Age range
18 Years – 55 Years
Sex
ALL
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Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Part 1a: Number of healthy volunteers with adverse events (AEs)
Timeframe: From screening (SAEs only) up to Final assessment (Day 7)
Part 2: Number of healthy volunteers with AEs
Timeframe: From screening (SAEs only) up to Final assessment (Day 13)
Part 1b: Maximum observed plasma (peak) drug concentration (Cmax)
Timeframe: From Day 1 to Day 3
Part 1b: Time to reach peak or maximum observed concentration or response following drug administration (tmax)
Timeframe: From Day 1 to Day 3
Part 1b: Terminal rate constant, estimated by log linear least squares regression of the terminal part of the concentration time curve (λz)
Timeframe: From Day 1 to Day 3
Part 1b: Half life associated with terminal slope (λz) of a semi logarithmic concentration time curve (t1/2λz)
Timeframe: From Day 1 to Day 3
Part 1b: Partial area under the plasma concentration time curve from time 0 to time 12 (AUC [0 - 12])
Timeframe: From Day 1 to Day 3
Part 1b: Partial area under the plasma concentration time curve from time 0 to time 24 (AUC [0 - 24])
Timeframe: From Day 1 to Day 3
Part 1b: Area under the plasma concentration curve from zero to the last quantifiable concentration (AUClast)
Timeframe: From Day 1 to Day 3
Part 1b: Apparent total body clearance of drug from plasma after extravascular administration (CL/F)
Timeframe: From Day 1 to Day 3
Part 1b: Total body clearance of drug from plasma after intravascular administration (CL)
Timeframe: From Day 1 to Day 3
Part 1b: Volume of distribution (apparent) at steady state following extravascular administration (based on terminal phase) (Vz/F)
Timeframe: From Day 1 to Day 3
Part 1b: Volume of distribution following intravascular administration (based on terminal phase) (Vz)
Timeframe: From Day 1 to Day 3
Part 1b: Dose normalized AUClast, derived by AUClast divided by the dose administered (AUClast/D)
Timeframe: From Day 1 to Day 3
Part 1b: Area under plasma concentration-time curve from zero to infinity (AUCinf)
Timeframe: From Day 1 to Day 3
Part 1b: Dose normalized AUCinf, derived by AUCinf divided by the dose administered (AUCinf/D)
Timeframe: From Day 1 to Day 3
Part 1b: Dose normalized Cmax, derived by Cmax divided by the dose administered (Cmax/D)
Timeframe: From Day 1 to Day 3
Part 1b: Time of last observed (quantifiable) concentration (tlast)
Timeframe: From Day 1 to Day 3
Part 3: Number of patients with AEs
Timeframe: From Screening (SAEs only) up to Final Assessment (Day 16)