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Corticosteroid
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
Phase 1
Waitlist Available
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-dose and post-dose: part a- (mad) days 1 to 17 and fu visit/et visit (10-day post-last dose); part b- days 1 to 14, day 28, day 29, and fu visit/ et visit (10-day post-last dose)
Summary
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.
Eligible Conditions
- Asthma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pre-dose and post-dose on days 1 to 4 and follow-up visit/et visit (7-day post-dose)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-dose and post-dose on days 1 to 4 and follow-up visit/et visit (7-day post-dose)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Part A (IV Cohort): Number of participants with adverse events
Part A (IV Cohort): Volume of distribution of drug from serum after IV administration (Vz) of AZD8630
Part A (IV cohort): Area under serum concentration-time curve from zero to infinity (AUCinf) of AZD8630
+11 moreSecondary study objectives
Part A (A1 and A2 only): Time of last observed quantifiable concentration (tlast) of AZD8630
Part A and Part B: Accumulation ratio based upon AUCt [Rac(AUC)] of AZD8630
Part A and Part B: Accumulation ratio based upon Cmax [Rac(Cmax)] of AZD8630
+19 moreTrial Design
10Treatment groups
Experimental Treatment
Placebo Group
Group I: Part B (AZD8630)Experimental Treatment1 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 Treatment1 Intervention
Healthy participants of Chinese and Japanese ethnicity will receive once daily inhaled dose 5 of AZD8630.
Group III: Part A3: MAD (AZD8630)Experimental Treatment1 Intervention
Healthy participants will receive once daily inhaled doses 3, 4, and 5 of AZD8630.
Group IV: Part A2: SAD (AZD8630)Experimental Treatment1 Intervention
Healthy participants of Chinese and Japanese ethnicity will receive single inhaled dose 5 of AZD8630.
Group V: Part A1: SAD (AZD8630)Experimental Treatment1 Intervention
Healthy participants will receive single inhaled doses 1 to 5 of AZD8630.
Group VI: Part A1: IV (AZD8630)Experimental Treatment1 Intervention
Healthy participants will receive a single IV dose of AZD8630.
Group VII: Part B (Placebo)Placebo Group1 Intervention
Participants with asthma will receive once daily inhaled dose of placebo.
Group VIII: Part A: MAD (Placebo)Placebo Group1 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 Group1 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 Group1 Intervention
Healthy participants will receive single IV dose of Placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AZD8630
2021
Completed Phase 1
~170
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
AstraZenecaLead Sponsor
4,411 Previous Clinical Trials
289,122,902 Total Patients Enrolled
348 Trials studying Asthma
656,575 Patients Enrolled for Asthma