A Study to Investigate the Safety, Tolerability and Effects of AZD8630 in Healthy Subjects and Subjects With Asthma on Inhaled Corticosteroids and Long-acting Beta-agonists

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

170 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a new drug, AZD8630, in healthy adults and asthma patients. It aims to see if the drug is safe and how it behaves in the body. The study involves both healthy volunteers and asthma patients who are already on certain medications.

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.

Eligibility Criteria

Inclusion Criteria

Chinese participants must be aged 18 to 45 years, inclusive

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.

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

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

Treatment Details

Interventions

• AZD8630
• Placebo

Participant Groups

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