AZD2389 Safety and Pharmacokinetics in 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

Healthy male and female (of non-childbearing potential) participants with suitable veins for cannulation or repeated venipuncture

Participants must have a BMI between 18 and 32 kg/m2 inclusive and weigh at least 50 kg at the Screening Visit

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day ≤ -28 (only sae), day -1 (only sae), days 1 to 12, day 17 (± 1 day)

Awards & highlights

Study Summary

This trial tests the safety and how a drug is used, absorbed, and affects the body when given in single and multiple doses to healthy people.

Who is the study for?

Healthy adults with a BMI of 18-32 and weight over 50 kg can join. Women must not be able to bear children, and men must use contraception. Participants should have good veins for blood draws, no serious health issues or drug abuse history, not smoke or drink excessively, and avoid certain medications before the trial. Specific groups include Japanese or Chinese descent individuals.Check my eligibility

What is being tested?

The study is testing AZD2389's safety and how it affects the body when given once (SAD) or multiple times (MAD). It compares AZD2389 against a placebo in healthy people to see what happens to the drug in their bodies and how they respond to it.See study design

What are the potential side effects?

Since this is an early-stage trial for AZD2389 in healthy volunteers, specific side effects are being investigated but are not yet known. Common side effects may include reactions at the injection site, nausea, headache, or fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am healthy, can't become pregnant, and have good veins for drawing blood.

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My BMI is between 18 and 32, and I weigh at least 50 kg.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day ≤ -28 (only sae), day -1 (only sae), days 1 to 12, day 17 (± 1 day)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day ≤ -28 (only sae), day -1 (only sae), days 1 to 12, day 17 (± 1 day)

This trial's timeline: 3 weeks for screening, Varies for treatment, and day ≤ -28 (only sae), day -1 (only sae), days 1 to 12, day 17 (± 1 day) 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 (SAD): Number of participants with adverse events (AE) and serious adverse events (SAE)

Part B (MAD): Number of participants with AE and SAE

Secondary outcome measures

Part A (SAD): Apparent terminal elimination half-life (t½λz)

Part A (SAD): Apparent total body clearance of drug (CL/F)

Part A (SAD): Apparent volume of distribution based on the terminal phase (Vz/F)

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Trial Design

13Treatment groups

Experimental Treatment

Group I: Cohort 9: Part A3 - AZD2389 dose 9 /placebo oral administrationExperimental Treatment2 Interventions