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AZD5462 for Healthy Subjects

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 between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up part a: day 1 (pre-dose and post-dose), and days 2, 3, and 10 (post-dose); part b: days 1 to 19 (pre and post-doses)

Summary

This trial tests a new drug called AZD5462 in healthy men and women, including Japanese participants. It aims to find out how safe the drug is and how the body processes it by giving different doses.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~part a: day 1 (pre-dose and post-dose), and days 2, 3, and 10 (post-dose); part b: days 1 to 19 (pre and post-doses)
This trial's timeline: 3 weeks for screening, Varies for treatment, and part a: day 1 (pre-dose and post-dose), and days 2, 3, and 10 (post-dose); part b: days 1 to 19 (pre and post-doses) for reporting.

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
Secondary study objectives
Area under plasma concentration time curve from zero to infinity (AUCinf) for AZD5462
Area under the plasma concentration curve from zero to the last quantifiable concentration (AUClast) for AZD5462
Maximum observed plasma (peak) drug concentration (Cmax) for AZD5462
+1 more

Trial Design

17Treatment groups
Experimental Treatment
Placebo Group
Group I: Cohort B5 Japanese descent: AZD5462 Dose 4Experimental Treatment1 Intervention
Randomized participants of Japanese descent will receive Dose 4 of AZD5462.
Group II: Cohort B4: AZD5462 Dose 4Experimental Treatment1 Intervention
Randomized healthy participants will receive Dose 4 of AZD5462.
Group III: Cohort B3: AZD5462 Dose 3Experimental Treatment1 Intervention
Randomized healthy participants will receive Dose 3 of AZD5462.
Group IV: Cohort B2: AZD5462 Dose 2Experimental Treatment1 Intervention
Randomized healthy participants will receive Dose 2 of AZD5462.
Group V: Cohort B1: AZD5462 Dose 1Experimental Treatment1 Intervention
Randomized healthy participants will receive Dose 1 of AZD5462.
Group VI: Cohort A8 Japanese descent: AZD5462 Dose 5Experimental Treatment1 Intervention
Randomized participants of Japanese descent will receive Dose 5 of AZD5462.
Group VII: Cohort A7: AZD5462 Dose 5Experimental Treatment1 Intervention
Randomized healthy participants will receive Dose 5 of AZD5462.
Group VIII: Cohort A6 Japanese descent: AZD5462 Dose 4Experimental Treatment1 Intervention
Randomized participants of Japanese descent will receive Dose 4 of AZD5462.
Group IX: Cohort A5: AZD5462 Dose 4Experimental Treatment1 Intervention
Randomized healthy participants will receive Dose 4 of AZD5462.
Group X: Cohort A4 Japanese descent: AZD5462 Dose 3Experimental Treatment1 Intervention
Randomized participants of Japanese descent will receive Dose 3 of AZD5462.
Group XI: Cohort A3: AZD5462 Dose 3Experimental Treatment1 Intervention
Randomized healthy participants will receive Dose 3 of AZD5462.
Group XII: Cohort A2: AZD5462 Dose 2Experimental Treatment1 Intervention
Randomized healthy participants will receive Dose 2 of AZD5462.
Group XIII: Cohort A1: AZD5462 Dose 1Experimental Treatment1 Intervention
Randomized healthy participants will receive Dose 1 of AZD5462.
Group XIV: Part A: Placebo (Healthy Participants)Placebo Group1 Intervention
Randomized healthy participants will receive Placebo matched to AZD5462.
Group XV: Part B: Placebo (Healthy participants)Placebo Group1 Intervention
Randomized healthy participants will receive Placebo matched to AZD5462.
Group XVI: Part B: Placebo (Japanese descent participants)Placebo Group1 Intervention
Randomized participants of Japanese descent will receive Placebo matched to AZD5462.
Group XVII: Part A: Placebo (Japanese descent participants)Placebo Group1 Intervention
Randomized participants of Japanese descent will receive Placebo matched to AZD5462.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AZD5462
2022
Completed Phase 1
~150

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,388 Previous Clinical Trials
289,109,725 Total Patients Enrolled
~23 spots leftby Nov 2025
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