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A Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD7503 in Healthy Participants
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) days 1 to 4
Summary
This trial tests a new drug, AZD7503, for safety and how it is processed in healthy men and women who cannot have children. The study will measure how the drug moves through and affects the body.
Eligible Conditions
- Tolerability
- Pharmacokinetics
- Healthy Subjects
- Safety
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ (pre-dose and post-dose) days 1 to 4 and final fu visit (week 10 post last dose) or et (assessed up to 14 weeks)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~(pre-dose and post-dose) days 1 to 4 and final fu visit (week 10 post last dose) or et (assessed up to 14 weeks)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of participants with Adverse Events (AEs)
Secondary study objectives
Apparent total body clearance of drug from plasma after extravascular administration (CL/F) of AZD7503
Apparent volume of distribution at steady state following extravascular administration (Vz/F) of AZD7503
Area under plasma concentration time-curve from zero to infinity (AUCinf) of AZD7503
+11 moreTrial Design
12Treatment groups
Experimental Treatment
Placebo Group
Group I: Japanese Cohort 2: AZD7503 dose 4Experimental Treatment1 Intervention
Randomised healthy Japanese participants will receive a single dose 4 of AZD7503.
Group II: Japanese Cohort 1: AZD7503 dose 3Experimental Treatment1 Intervention
Randomised healthy Japanese participants will receive a single dose 3 of AZD7503.
Group III: Cohort 6: AZD7503 dose YExperimental Treatment1 Intervention
Randomised healthy participants will receive a single dose Y of AZD7503.
Group IV: Cohort 5 : AZD7503 dose XExperimental Treatment1 Intervention
Randomised healthy participants will receive a single dose X of AZD7503.
Group V: Cohort 4: AZD7503 dose 4Experimental Treatment1 Intervention
Randomised healthy participants will receive a single dose 4 of AZD7503.
Group VI: Cohort 3: AZD7503 dose 3Experimental Treatment1 Intervention
Randomised healthy participants will receive a single dose 3 of AZD7503.
Group VII: Cohort 2: AZD7503 dose 2Experimental Treatment1 Intervention
Randomised healthy participants will receive a single dose 2 of AZD7503.
Group VIII: Cohort 1: AZD7503 dose 1Experimental Treatment1 Intervention
Randomised healthy participants will receive a single dose 1 of AZD7503.
Group IX: Chinese Cohort: AZD7503 dose 4Experimental Treatment1 Intervention
Randomised healthy Chinese participants will receive a single dose 4 of AZD7503.
Group X: Pooled Placebo for AZD7503 (Cohorts 1 to 6)Placebo Group1 Intervention
Randomised healthy participants will receive placebo.
Group XI: Placebo (Japanese Cohorts)Placebo Group1 Intervention
Randomised healthy Japanese participants will receive placebo.
Group XII: Placebo (Chinese Cohort)Placebo Group1 Intervention
Randomised healthy Chinese participants will receive placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AZD7503
2021
Completed Phase 1
~60
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
AstraZenecaLead Sponsor
4,427 Previous Clinical Trials
289,164,543 Total Patients Enrolled
27 Trials studying Pharmacokinetics
1,402 Patients Enrolled for Pharmacokinetics