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Corticosteroid

AZD6793 for Healthy Subjects

Phase 1
Recruiting
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 from day 1 up to follow up visit (day 14±1)
Awards & highlights

Summary

This trial aims to investigate how safe and well-tolerated a new oral medication, AZD6793, is in healthy Japanese and Chinese individuals, as well as how the body processes this medication.

Who is the study for?
This trial is for healthy Japanese and Chinese adults with a BMI of 18-30 kg/m2, weighing at least 45 kg. Participants must have all four grandparents and both parents of the same nationality without living abroad over 10 years. Women must test negative for pregnancy, not be breastfeeding, use contraception if applicable, or be non-childbearing due to menopause or surgery.
What is being tested?
The study tests AZD6793's safety and how it's processed in the body when taken orally by healthy participants compared to a placebo. It specifically involves Japanese and Chinese individuals to understand any ethnic differences in drug response.
What are the potential side effects?
While specific side effects are not listed as this is an initial safety trial, common ones may include nausea, headache, dizziness or allergic reactions. The study aims to identify these potential adverse effects.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from day 1 up to follow up visit (day 14±1)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from day 1 up to follow up visit (day 14±1) 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 1 (SAD): Number of Participants with Adverse Events
Part 2 (MAD): Number of Participants with Adverse Events
Secondary outcome measures
Part 1 (SAD) : Maximum Observed Plasma Drug Concentration
Part 1 (SAD): Apparent Total Body Clearance of Drug from Plasma After Extravascular Administration (CL/F)
Part 1 (SAD): Area Under the Plasma Concentration Curve from Time Zero to the Last Quantifiable Concentration (AUClast)
+30 more

Trial Design

5Treatment groups
Experimental Treatment
Group I: Part 2: Cohort 2 AZD6793Experimental Treatment2 Interventions
6 Chinese participants will receive single dose of AZD6793 and 2 participants will receive matching placebo on Day 1. After a washout of at least 48 hours, participants will receive AZD6793 or placebo once daily from Day 3 to Day 8.
Group II: Part 2: Cohort 1 AZD6793Experimental Treatment2 Interventions
6 Japanese participants will receive single dose of AZD6793 and 2 participants will receive matching placebo on Day 1. After a washout of at least 48 hours, participants will receive AZD6793 or placebo once daily from Day 3 to Day 8.
Group III: Part 1: Cohort 3 AZD6793Experimental Treatment2 Interventions
6 Healthy Chinese participants will receive single dose of AZD6793 dose 1 and 2 healthy Chinese participants will receive matching placebo to AZD6793 as oral suspension on Day 1.
Group IV: Part 1: Cohort 2 AZD6793Experimental Treatment2 Interventions
6 Healthy Japanese participants will receive single dose of AZD6793 dose 2 and 2 healthy Japanese participants will receive matching placebo to AZD6793 as oral suspension on Day 1.
Group V: Part 1: Cohort 1 AZD6793Experimental Treatment2 Interventions
6 Healthy Japanese participants will receive single dose of AZD6793 dose 1 and 2 healthy Japanese participants will receive matching placebo to AZD6793 as oral suspension on Day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

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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
4,352 Previous Clinical Trials
288,646,769 Total Patients Enrolled
~8 spots leftby Oct 2024
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