AZD6793 / AstraZeneca - LARVOL DELTA

AZD6793, A Novel IRAK4 Inhibitor, Targets Multiple Disease-relevant Pathways in Pre-clinical Models of Chronic Obstructive Pulmonary Disease (ATS 2025) - "Importantly, AZD6793 efficiently blocked inflammation that could not be suppressed by steroids in models of IL-1β and IL-36γ-induced inflammation. CONCLUSION Overall, our data indicate that IRAK4 is a central regulator of multiple inflammatory processes in the airways and support the development of AZD6793 as a novel therapeutic approach in COPD."

IO biomarker • Preclinical • Chronic Obstructive Pulmonary Disease • Immunology • Infectious Disease • Inflammation • Pulmonary Disease • Respiratory Diseases • ELANE • IL1B • IL1R1 • IL33 • IL5 • IRAK4 • MUC5AC

A Study to Investigate the Safety and Pharmacokinetics of AZD6793 in Healthy Japanese and Chinese Participants (clinicaltrials.gov) - P1 | N=39 | Completed | Sponsor: AstraZeneca | Active, not recruiting ➔ Completed

Trial completion

A Study to Investigate the Safety and Pharmacokinetics of AZD6793 in Healthy Japanese and Chinese Participants (clinicaltrials.gov) - P1 | N=39 | Active, not recruiting | Sponsor: AstraZeneca | Recruiting ➔ Active, not recruiting

Enrollment closed

A Study to Investigate the Safety, Tolerability, and Pharmacokinetics (PK) of Oral AZD6793 in Healthy and Chronic Obstructive Pulmonary Disease Participants, to Assess the Relative Oral Bioavailability Between Two Formulations, and the Food Effect on the PK of AZD6793 Compared to Fasting State. (clinicaltrials.gov) - P1 | N=93 | Completed | Sponsor: AstraZeneca | Recruiting ➔ Completed

Trial completion • Chronic Obstructive Pulmonary Disease • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases

A Study to Assess the Pharmacokinetics of AZD6793 When Administered Alone and in Combination With Itraconazole in Healthy Participants. (clinicaltrials.gov) - P1 | N=17 | Completed | Sponsor: AstraZeneca | Active, not recruiting ➔ Completed

Combination therapy • Trial completion

A Study to Assess the Pharmacokinetics of AZD6793 When Administered Alone and in Combination With Itraconazole in Healthy Participants. (clinicaltrials.gov) - P1 | N=8 | Active, not recruiting | Sponsor: AstraZeneca | Recruiting ➔ Active, not recruiting | N=18 ➔ 8

Combination therapy • Enrollment change • Enrollment closed

A Study to Assess the Pharmacokinetics of AZD6793 When Administered Alone and in Combination With Itraconazole in Healthy Participants. (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: AstraZeneca | N=48 ➔ 18

Combination therapy • Enrollment change

A Study to Assess the Pharmacokinetics of AZD6793 When Administered Alone and in Combination With Itraconazole in Healthy Participants. (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: AstraZeneca | Not yet recruiting ➔ Recruiting | N=16 ➔ 48

Combination therapy • Enrollment change • Enrollment open

A Study to Investigate the Safety, Tolerability, and Pharmacokinetics (PK) of Oral AZD6793 in Healthy and Chronic Obstructive Pulmonary Disease Participants, to Assess the Relative Oral Bioavailability Between Two Formulations, and the Food Effect on the PK of AZD6793 Compared to Fasting State. (clinicaltrials.gov) - P1 | N=93 | Recruiting | Sponsor: AstraZeneca | N=133 ➔ 93

Enrollment change • Chronic Obstructive Pulmonary Disease • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases

A Study to Assess the Pharmacokinetics of AZD6793 When Administered Alone and in Combination With Itraconazole in Healthy Participants. (clinicaltrials.gov) - P1 | N=16 | Not yet recruiting | Sponsor: AstraZeneca

Combination therapy • New P1 trial

A Study to Investigate the Safety and Pharmacokinetics of AZD6793 in Healthy Japanese and Chinese Participants (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: AstraZeneca | Not yet recruiting ➔ Recruiting

Enrollment open

A Study to Investigate the Safety and Pharmacokinetics of AZD6793 in Healthy Japanese and Chinese Participants (clinicaltrials.gov) - P1 | N=40 | Not yet recruiting | Sponsor: AstraZeneca

New P1 trial

A Study to Investigate the Safety, Tolerability, and Pharmacokinetics (PK) of Oral AZD6793 in Healthy Subjects and to Assess the Relative Oral Bioavailability Between Two Formulations. The Study Will Also Assess the Food Effect on the PK of AZD6793 Compared to Fasting State (clinicaltrials.gov) - P1 | N=133 | Recruiting | Sponsor: AstraZeneca | Trial completion date: Mar 2024 ➔ Sep 2024 | Trial primary completion date: Mar 2024 ➔ Sep 2024

Trial completion date • Trial primary completion date • Chronic Obstructive Pulmonary Disease • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases

A Study to Investigate the Safety, Tolerability, and Pharmacokinetics (PK) of Oral AZD6793 in Healthy Subjects (clinicaltrials.gov) - P1 | N=133 | Recruiting | Sponsor: AstraZeneca | Trial completion date: Aug 2023 ➔ Mar 2024 | Trial primary completion date: Aug 2023 ➔ Mar 2024

Trial completion date • Trial primary completion date • Inflammation

A Study to Investigate the Safety, Tolerability, and Pharmacokinetics (PK) of Oral AZD6793 in Healthy Subjects (clinicaltrials.gov) - P1 | N=133 | Recruiting | Sponsor: AstraZeneca | N=24 ➔ 133

Enrollment change • Inflammation

A Study to Investigate the Safety, Tolerability, and Pharmacokinetics (PK) of Oral AZD6793 in Healthy Subjects (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: AstraZeneca | N=133 ➔ 24

Enrollment change • Inflammation

A Study to Investigate the Safety, Tolerability, and Pharmacokinetics (PK) of Oral AZD6793 in Healthy Subjects (clinicaltrials.gov) - P1 | N=133 | Recruiting | Sponsor: AstraZeneca

New P1 trial • Inflammation