AZD8630 for Asthma

No longer recruiting at 29 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: AstraZeneca

Must be taking: Inhaled corticosteroids, Long-acting beta-agonists

Must not be taking: Biologics, Systemic steroids

Disqualifiers: Cancer, COPD, COVID-19, others

Compensation: Varies

Number of Visits: Unknown

Duration: Part A: Up to 87 days, Part B: Up to 70 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and effects of a new treatment called AZD8630. It consists of two parts: one for healthy participants and another for asthma patients who use inhaled corticosteroids and long-acting beta-agonists. The goal is to ensure AZD8630 is safe and to observe its behavior in the body. Adults with asthma, diagnosed for more than six months and experiencing frequent symptoms despite treatment, might be suitable for the asthma part of the trial. As a Phase 1 trial, this research focuses on understanding how AZD8630 works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

Yes, participants must stop taking any prescribed or nonprescribed medications during the 2 weeks before the first administration of the study drug. Additionally, specific asthma medications must be stopped within certain timeframes before screening.

Is there any evidence suggesting that AZD8630 is likely to be safe for humans?

Research shows that AZD8630 is undergoing its first human trials to assess safety. Earlier studies with healthy participants found the treatment to be generally well-tolerated. These studies examined the body's processing of the drug and monitored immune system reactions. No serious side effects have been reported so far.

However, as this is an early-stage trial, researchers are still learning about the full safety profile of AZD8630. They continue to gather information on its safety. The treatment's presence in this initial testing phase suggests promise in lab settings, but human study data remains limited. Participants in these trials receive close monitoring for any side effects to ensure their safety. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for asthma?

AZD8630 is unique because it offers a new approach to treating asthma by potentially enhancing the effectiveness of existing inhaled corticosteroids and long-acting beta-agonists. Unlike current treatments, AZD8630 is being explored for its novel inhaled and intravenous delivery methods, which may improve drug absorption and impact. Researchers are particularly excited about its potential to target asthma more directly and effectively, offering hope for improved management of symptoms and better quality of life for patients.

What evidence suggests that AZD8630 might be an effective treatment for asthma?

Research has shown that AZD8630, which participants in this trial may receive, may help treat asthma by improving breathing and reducing asthma attacks. In studies, patients using AZD8630 performed better on lung function tests, such as FEV1, which measures the volume of air exhaled in one second. This indicates improved breathing. Additionally, patients experienced better asthma control and an enhanced overall quality of life. Overall, AZD8630 has the potential to help people with asthma manage their symptoms more effectively. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

Inclusion Criteria

Females must have a negative serum pregnancy test at the Screening Visit and a negative urine pregnancy test on admission to the Clinical Unit, must not be lactating, and must be of non childbearing potential, confirmed at the Screening Visit

Have a body mass index (BMI) between 18 and 30 kg/m^2 inclusive and weigh at least 45 kg.

Part A (Healthy participants):

Exclusion Criteria

Participants who have previously received AZD8630.

Unwilling to defer SARS-CoV-2 vaccination during the study period.

History of cancer within last 10 years (20 years for breast cancer) except for basal and squamous cell carcinoma of skin or in situ carcinoma of cervix treated and considered cured. Any history of lymphoma is not allowed.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 4 weeks

Treatment

Participants receive AZD8630 or placebo in single and multiple ascending dose cohorts

Part A: Up to 87 days, Part B: Up to 70 days

Multiple visits for dosing and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

7 to 10 days post-last dose

Follow-up visit

What Are the Treatments Tested in This Trial?

Interventions

• AZD8630
• Placebo

How Is the Trial Designed?

Group I: Part B (AZD8630) Experimental Treatment 1 Intervention

Participants with asthma will be randomized to one of 3 inhaled dose levels 3, 6, and 7 of AZD8630 once daily.

Group II: Part A4: MAD (AZD8630) Experimental Treatment 1 Intervention

Healthy participants of Chinese and Japanese ethnicity will receive once daily inhaled dose 5 of AZD8630.

Group III: Part A3: MAD (AZD8630) Experimental Treatment 1 Intervention

Healthy participants will receive once daily inhaled doses 3, 4, and 5 of AZD8630.

Group IV: Part A2: SAD (AZD8630) Experimental Treatment 1 Intervention

Healthy participants of Chinese and Japanese ethnicity will receive single inhaled dose 5 of AZD8630.

Group V: Part A1: SAD (AZD8630) Experimental Treatment 1 Intervention

Healthy participants will receive single inhaled doses 1 to 5 of AZD8630.

Group VI: Part A1: IV (AZD8630) Experimental Treatment 1 Intervention

Healthy participants will receive a single IV dose of AZD8630.

Group VII: Part B (Placebo) Placebo Group 1 Intervention

Participants with asthma will receive once daily inhaled dose of placebo.

Group VIII: Part A: MAD (Placebo) Placebo Group 1 Intervention

Healthy participants and healthy participants of Chinese and Japanese ethnicity will receive once daily inhaled dose of placebo.

Group IX: Part A: SAD (Placebo) Placebo Group 1 Intervention

Healthy participants and healthy participants of Chinese and Japanese ethnicity will receive single inhaled doses of placebo.

Group X: Part A1: IV (Placebo) Placebo Group 1 Intervention

Healthy participants will receive single IV dose of Placebo.

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06529419

NCT06529419 | A Dose Range-Finding Study to Assess ... This is a Phase II, randomised, placebo-controlled, double-blind, dose range-finding, multi-centre study to assess the efficacy and safety of inhaled AZD8630 ...

2. astrazenecaclinicaltrials.com astrazenecaclinicaltrials.com/study/D6830C00003

A Dose Range-Finding Study to Assess the Efficacy and ... A dose range-finding study to assess the efficacy and safety of multiple dose levels of AZD8630 administered via a dry powder inhaler in adults with ...

3. clinicaltrials.eu clinicaltrials.eu/inn/azd8630/

Azd8630 – Application in Therapy and Current Clinical ... Key outcomes include safety measures like adverse events, measures of lung function like FEV1, asthma control questionnaires, quality of life assessments, time ...

4. withpower.com withpower.com/trial/azd8630-for-uncontrolled-asthma-0cae6

AZD8630 for Uncontrolled Asthma (Levante Trial) The research on tezepelumab, a drug used for severe, uncontrolled asthma, shows it can reduce asthma attacks by up to 71% and improve lung function and quality ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05110976

NCT05110976 | A Study to Investigate the Safety, ... This is a first in human (FIH) clinical study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD8630 in healthy adults.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06795906

Study Details | NCT06795906 | A Safety, Pharmacokinetic, ... The purpose of this study is to assess the safety, PK, and PD of AZD8630 compared to placebo in participants with asthma and elevated fractional exhaled nitric ...

7. publications.ersnet.org publications.ersnet.org/content/erj/64/suppl68/pa3558

Pharmacokinetics of AZD8630/AMG 104 inhaled anti-TSLP in ... This Phase1 study (NCT05110976) aimed to characterize safety, tolerability, pharmacokinetics (PK) and immunogenicity of AZD8630/AMG 104 in healthy volunteers ...

8. astrazenecaclinicaltrials.com astrazenecaclinicaltrials.com/study/D6830C00005

A Study of Inhaled AZD8630 in Adolescents with Asthma The purpose of this study is to evaluate the pharmacokinetic (PK) profile, safety, tolerability, and immunogenicity of single inhaled dose of AZD8630 ...

9. astrazenecaclinicaltrials.com astrazenecaclinicaltrials.com/study/D6830C00001

A Study to Investigate the Safety, Tolerability and Effects of ... This is a first in human (FIH) clinical study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD8630 in healthy adults (Part ...