A Safety, Pharmacokinetic, and Pharmacodynamic Study of Once Daily Inhaled AZD8630 in Adults With Asthma

NCT06795906 | Completed Phase 1

• 1 other identifier: D6830C00004
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 3

Brief Summary

This is a randomised, placebo-controlled, double-blinded, sponsor-unblinded study to assess the safety, pharmacokinetic (PK), and pharmacodynamic (PD) effect of AZD8630 in adult participants with asthma on medium-to-high dose inhaled corticosteroids (ICS) and long-acting beta-agonists (LABA).

Conditions

Asthma

Keywords

Inhaled corticosteroids; Long-acting beta-agonists

Outcome Measures

Primary Outcomes (4)

• Number of adverse events (AEs) and serious adverse events (SAEs)

  To assess the safety and tolerability of AZD8630 Dose A daily (QD) in participants with asthma on medium-to-high dose ICS and LABA.

  From Screening (Day -28) to Follow up (Day 21)

• Number of adverse events leading to discontinuation (DAEs)

  To assess the safety and tolerability of AZD8630 Dose A QD in participants with asthma on medium-to-high dose ICS and LABA.

  From Day 1 to Day 14

• Area under the plasma concentration curve from zero to the last quantifiable concentration (AUClast)

  To assess the PK of AZD8630 Dose A QD in participants with asthma on medium-to-high dose ICS and LABA.

  Day 1, Day 14 and Follow up (Day 21)

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

  To assess the PK of AZD8630 Dose A QD in participants with asthma on medium-to-high dose ICS and LABA.

  Day 1, Day 14 and Follow up (Day 21)

Secondary Outcomes (5)

• Change from baseline in fractional exhaled nitric oxide (FeNO) at Weeks 1 and 2

  From Screening (Day -28) to Follow up (Day 21)

• Incidence of anti-drug antibodies (ADAs) in serum

  Day 1, Day 14 and Follow up (Day 21)

• Incidence of AEs and SAEs associated with the Saphira device

  Day 1 to Day 14

• Incidence of Saphira device deficiencies (DDs)

  Day 1 to Day 14

• Incidence of participant confirmation of dose administration following inhalation

  Day 1 to Day 14

Study Arms (2)

AZD8630 Dose A

EXPERIMENTAL

Participants will self-administer AZD8630 Dose A daily from Day 1 up to Day 14.

Drug: AZD8630; Device: Saphira device

Placebo

PLACEBO COMPARATOR

Participants will self-administer corresponding placebo daily from Day 1 up to Day 14.

Other: Placebo; Device: Saphira device

Interventions

AZD8630 DRUG

AZD8630 will be administered via dry powder inhalation (DPI).

AZD8630 Dose A

Placebo OTHER

Placebo will be administered via DPI.

Placebo

Saphira device DEVICE

AZD8630 or placebo will be administered to participants via Saphira device.

AZD8630 Dose A; Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants who have documented physician-diagnosis of asthma for at least 12 months, as evidenced by any of the following:
• Post-bronchodilator (BD) reversibility of FEV1 ≥ 12% and ≥ 200 milliliters (mL) within 5 years prior to Visit 1, at Visit 1 or
• Peak expiratory flow (PEF) average daily variability \> 10% over a 2-week period within 5 years prior to Visit 1, or
• Variability of FEV1 \> 12% and 200 mL between any 2 clinical visits within 5 years prior to Visit 1, or
• Positive bronchial challenge test within 5 years prior to Visit 1. A positive test is defined as a fall in FEV1 from pre-challenge of ≥ 20% with standard doses of methacholine or ≥ 5% with standardised hyperventilation, hypertonic saline, or mannitol challenge, or
• Positive exercise challenge test within 5 years prior to Visit 1. A positive test is defined as a fall in FEV1 of \> 10% and \> 200 mL from pre-challenge, or
• Significant increase in lung function after 4 weeks of Inhaled Corticosteroids (ICS) anti-inflammatory treatment within 5 years prior to Visit 1, defined as an increase in FEV1 \> 12% and 200 mL (or PEF by \> 20%).
• Treated with medium or high dose ICS (as per GINA 2023) in combination with long-acting beta-agonists (LABA) (GINA step 4 or 5 therapy); the dose of ICS must be stable for at least 30 days prior to Visit 1. The ICS can be contained within an ICS-LABA fixed-dose combination product.
• \- Treatment with additional asthma controller therapies (eg, long-acting muscarinic-agonists) at a stable dose ≥ 30 days prior to Visit 1 is allowed.
• Asthma Control Questionnaire-6 (ACQ-6) score in the range 0.75-3 at both screening and randomisation.
• Pre-bronchodilator FEV1 ≥ 40%. 6 FeNO ≥ 30 parts per billion (ppb) at both screening and randomisation. 7 At least 70% compliance with usual asthma background medication during the screening period (14 days prior to randomisation) based on the daily asthma ePROs. At least 70% compliance with electronically recorded participant reported outcomes (ePRO) device completion during the screening period (14 days prior to randomisation). This is defined as completing the ePRO any 10 mornings and 10 evenings in the last 14 days prior to randomisation.
• Minimum 70% compliance with PEF measurements during the screening period (14 days prior to randomisation). This is defined as performing PEF for any 10 mornings and any 10 evenings in the last 14 days prior to randomisation.
• Body mass index (BMI) within the range 18 to 35 kilograms per meter (kg/m2) inclusive and weight at least 45 kg at the time of signing the informed consent.

You may not qualify if:

• Life-threatening asthma defined as a history of significant asthma episode(s) involving intubation, respiratory arrest, hypoxic seizures, or asthma-related syncopal episode(s).
• Completed treatment for respiratory infection and/or asthma exacerbation with systemic corticosteroids and/or antibiotics in the 4 weeks prior to Visit 1 or during the screening period.
• Clinically important pulmonary disease other than asthma; including but not limited to participants with co-existent chronic obstructive pulmonary disease (COPD).
• Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric, or major physical impairment that is not stable in the opinion of the investigator and could:
• Affect the safety of the participant throughout the study.
• Influence the findings of the study or the interpretation.
• Impede the participant's ability to complete the entire study.
• Participants who, in the opinion of the investigator, have evidence of active tuberculosis (TB) or are currently on treatment for active or latent TB. Investigation for active or latent TB with interferon gamma release assay (IGRA) and/or chest X-ray should only be considered if deemed clinically indicated by the Principal Investigator.
• Medical history of or treatment for hepatitis B or hepatitis C, except for cured hepatitis C, as defined by:
• Positive test for hepatitis B surface antigen (HBsAg).
• Positive test for anti- hepatitis B core antibody (HBc Ab): Participants who test positive for anti-HBc Ab but negative for HBsAg may be enrolled if their hepatitis B virus (HBV) DNA test result is negative.
• Positive test for anti-hepatitis C antibody: Participants who test positive for anti-hepatitis C antibody may be enrolled if their hepatitis C viral ribonucleic acid (RNA) test result is negative in the absence of cirrhosis.
• Participants with known human immunodeficiency virus (HIV) or with a positive HIV test at screening.
• Any other clinically relevant abnormal findings in laboratory testing including haematology and clinical chemistry, on vital signs, electrocardiogram (ECG), or physical examination between consent and randomisation, that in the opinion of the investigator or medical monitor, might compromise the safety of the participant in the study or interfere with evaluation of the study intervention. Abnormal findings include, but are not limited to:
• Alanine aminotransferase/transaminase (ALT) or aspartate aminotransferase/transaminase AST \> 2 × upper limit of normal (ULN).

Sponsors & Collaborators

• AstraZeneca: lead
• Parexel: collaborator

Study Sites (3)

Research Site

Ahrensburg, 22926, Germany

Location

Research Site

Berlin, 10119, Germany

Location

Research Site

Mainz, 55128, Germany

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

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

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: January 28, 2025
• Study Start: January 28, 2025
• Primary Completion: June 27, 2025
• Study Completion: June 27, 2025
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma 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. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

DE (3)