AZD8630 for Asthma
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.12345Why 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.26789
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive AZD8630 or placebo in single and multiple ascending dose cohorts
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- AZD8630
- Placebo
How Is the Trial Designed?
10
Treatment groups
Experimental Treatment
Placebo Group
Participants with asthma will be randomized to one of 3 inhaled dose levels 3, 6, and 7 of AZD8630 once daily.
Healthy participants of Chinese and Japanese ethnicity will receive once daily inhaled dose 5 of AZD8630.
Healthy participants will receive once daily inhaled doses 3, 4, and 5 of AZD8630.
Healthy participants of Chinese and Japanese ethnicity will receive single inhaled dose 5 of AZD8630.
Healthy participants will receive single inhaled doses 1 to 5 of AZD8630.
Healthy participants will receive a single IV dose of AZD8630.
Participants with asthma will receive once daily inhaled dose of placebo.
Healthy participants and healthy participants of Chinese and Japanese ethnicity will receive once daily inhaled dose of placebo.
Healthy participants and healthy participants of Chinese and Japanese ethnicity will receive single inhaled doses of placebo.
Healthy participants will receive single IV dose of Placebo.
Find a Clinic Near You
Who Is Running the Clinical Trial?
AstraZeneca
Lead Sponsor
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
NCT06529419 | A Dose Range-Finding Study to Assess ...
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Key outcomes include safety measures like adverse events, measures of lung function like FEV1, asthma control questionnaires, quality of life assessments, time ...
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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.
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 ...
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 ...
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 ...
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 ...
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