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Compensation: Varies

Number of Visits: 11

176 Participants Needed

AZD3974 for Healthy Subjects

Recruiting at 1 trial location

Overseen ByAstraZeneca Clinical Study Information Center

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: AstraZeneca

Disqualifiers: Gastrointestinal, Hepatic, Renal, Alcohol, others

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called AZD3974 to assess its safety and how the body processes it. Researchers focus on healthy individuals, including those of Japanese and Chinese descent, to understand how different doses work. The trial includes several groups, each receiving different doses of AZD3974 or a placebo (a substance with no active drug), with some groups examining the effects of food on the medication. Healthy individuals with no major health issues and not on interfering medications might be suitable participants. Participants should maintain a healthy weight and have no history of significant medical conditions that could affect the study results. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, since the study is for healthy participants, it's likely that you should not be on any regular medications. Please check with the trial coordinators for specific guidance.

Is there any evidence suggesting that AZD3974 is likely to be safe for humans?

Research has shown that AZD3974 is being tested for safety and tolerance in healthy individuals. This Phase 1 trial aims to determine how people react to the drug and identify potential side effects. The goal is to gather information on AZD3974's safety for humans, though detailed results from this study are not yet available. Typically, Phase 1 trials use small doses to monitor for negative effects, with serious problems being rare at this stage. This trial includes participants from diverse backgrounds, including those of Japanese and Chinese descent, to assess the drug's effects across various groups.¹ ² ³ ⁴ ⁵

Why do researchers think this study treatment might be promising?

Researchers are excited about AZD3974 because it represents a new approach to drug development by focusing on its effects in healthy individuals before moving on to specific conditions. Unlike existing treatments that directly target diseases, AZD3974 is being tested for its safety and how the body processes it. This foundational research is critical for understanding its potential use in future therapies, potentially leading to more effective treatments with fewer side effects. Additionally, by studying food effects and varying doses, researchers aim to optimize its administration, which could enhance patient adherence and outcomes in eventual therapeutic applications.

What evidence suggests that AZD3974 could be effective?

Available research provides limited data on AZD3974's effectiveness in treating conditions. This trial tests AZD3974 in healthy subjects to ensure safety and understand its action in the body. Although detailed information on AZD3974's effectiveness is not yet available, early studies, including this trial, focus on its safety and pharmacokinetics. This information is crucial before exploring potential benefits for specific medical conditions.¹ ⁵ ⁶ ⁷ ⁸

Are You a Good Fit for This Trial?

This trial is for healthy individuals, including those of Japanese and Chinese descent. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and not have conditions that could interfere with the study.

Inclusion Criteria

I have good veins for blood draws and am not able to become pregnant.

For healthy Japanese cohorts (Part A2 and Part B2): healthy male and female participants are to be Japanese (eg, natives of Japan or Japan Americans), defined as having both parents and 4 grandparents who are Japanese. This includes second and third generation participants of Japanese descent whose parents or grandparents are living in a country other than Japan

For healthy Chinese cohort (Part A3): healthy male and female Chinese participants for whom both parents and 4 grandparents are Chinese. This includes second and third generation participants of Chinese descent whose parents or grandparents are living in a country other than China

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Exclusion Criteria

I haven't had any major illnesses or surgeries in the last 4 weeks.

Any abnormal laboratory values, vital signs, or any clinically important abnormalities in clinical chemistry, hematology, or urinalysis results

Any positive result on Screening for serum hepatitis B and C viruses and human immunodeficiency virus

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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Single Ascending Dose (SAD)

Participants receive a single dose of AZD3974 or placebo across multiple cohorts to assess safety and pharmacokinetics

1-2 days per cohort

1 visit (in-person) per cohort

Multiple Ascending Dose (MAD)

Participants receive multiple doses of AZD3974 or placebo across multiple cohorts to assess safety and pharmacokinetics

9 days per cohort

Multiple visits (in-person) over 9 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

AZD3974

Trial Overview

The study is testing AZD3974, a new medication given orally. Participants will be randomly assigned to receive either AZD3974 or a placebo (a substance with no therapeutic effect) to evaluate the drug's safety, tolerability, and how it's processed by the body.

How Is the Trial Designed?

Treatment groups

Experimental Treatment

Placebo Group

Group I: Part B2 (MAD) optional additional Japanese Cohort 2: AZD3974Experimental Treatment1 Intervention

Healthy Japanese participants will receive multiple doses of matching placebo to AZD3974

Group II: Part B2 (MAD) Japanese Cohort 1: AZD3974Experimental Treatment1 Intervention

Healthy Japanese participants will receive multiple doses of AZD397

Group III: Part B1 (MAD) optional additional Cohort 6: AZD3974Experimental Treatment1 Intervention