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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)

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ from day 1 up to follow up visit (day 14±1)

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Part 1 (SAD): Number of Participants with Adverse Events

Part 2 (MAD): Number of Participants with Adverse Events

Secondary study objectives

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

AZD6793

2022

Completed Phase 1

~110

Placebo

1995

Completed Phase 3

~2670