← Back to Search

Corticosteroid

AZD8630 for Asthma

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)
Awards & highlights

Study Summary

This trial is testing a new drug to see if it is safe and effective in adults with asthma.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-dose and post-dose: part a- (sad) days 1 to 4 and fu visit/et visit (7-day post-dose), (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)
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose and post-dose: part a- (sad) days 1 to 4 and fu visit/et visit (7-day post-dose), (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) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 more
Secondary outcome measures
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 more

Trial 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 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 VIII: 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 IX: Part B (Placebo)Placebo Group1 Intervention
Participants with asthma will receive once daily inhaled dose 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
4,238 Previous Clinical Trials
288,471,251 Total Patients Enrolled
328 Trials studying Asthma
639,464 Patients Enrolled for Asthma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new volunteers still able to register for this research endeavor?

"Affirmative. Clinicaltrials.gov data indicates that this trial, which was initially posted on December 16th 2021, is presently searching for participants. Approximately 240 patients must be recruited from 1 medical centre."

Answered by AI

Has the United States Food and Drug Administration sanctioned AZD8630 for therapeutic use?

"Since this is a preliminary trial, our team at Power assigned AZD8630 a score of 1 since there is only scant evidence outlining its safety and efficacy."

Answered by AI

What is the current enrollment rate for this clinical research project?

"Affirmative. On clinicaltrials.gov, it is shown that recruitment for this medical investigation began on December 16th 2021 and the latest update was November 16th 2022. This research requires 240 individuals to join from 1 site."

Answered by AI

Is it a requirement that prospective participants in this research must be under the age of 65?

"This research trial is open to adults between the ages of 18 and 75. There are 113 studies for minors and 198 programs designed for elderly people."

Answered by AI

What are the primary aims of this experiment?

"The primary outcome to be measured during the Pre-dose, Post-Dose (Days 1 - 4) and Follow Up/ET Visit (7 day post dose) time frames is the amount of participants with adverse events in Part A & B. Secondary objectives include assessing the Area under Plasma Concentration Time Curve divided by Lung Delivered Dose(AUCt/LDD), maximum serum concentration divided by lung delivered dose [Cmax/LDD] and area under serum concentration time curve (AUCt). All results will incorporate data from healthy individuals belonging to both Japanese and Chinese ethnicities."

Answered by AI

Are there any particular demographics that are favored to participate in this research?

"This clinical trial seeks to recruit 240 individuals who are currently affected by asthma, ranging in age from 18-75. In addition to this criterion, Japanese participants must be between 20 and 55 years of age while Chinese participants have a lower limit of 18 but an upper limit of 45; any female enrollees will require negative pregnancy tests as well as confirmation that they are not lactating nor capable of bearing children followed by the use highly effective contraception for both them and their male partners. All prospective patients should fall within the BMI range of 18-35 kg/m^2 with a minimum weight requirement of 45kg; furthermore, those born in Japan"

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
~52 spots leftby Mar 2025