What is the mechanism of action of this treatment?

The mechanisms of action for common treatments in healthy subjects generally involve understanding pharmacokinetics (PK) and pharmacodynamics (PD). PK studies how a drug is absorbed, distributed, metabolized, and excreted by the body, while PD examines the biological effects of the drug and its mechanism of action at the target site. This knowledge is essential for ensuring the safety and efficacy of new treatments, as it helps predict the drug's behavior in the body and potential side effects. For investigational drugs like AZD4144, these studies are critical in establishing appropriate dosing regimens and identifying any adverse reactions in healthy subjects before proceeding to patient populations.

What side effects are associated with this type of intervention?

Common side effects observed in clinical trials of investigational drugs like AZD4144 often include mild to moderate adverse events such as gastrointestinal distress (nausea, diarrhea), headache, fatigue, and dizziness. More specific side effects can vary depending on the drug's mechanism of action, but general observations also include local reactions at the administration site, such as erythema or pain, and occasional allergic reactions like rash or pruritus. Serious adverse events are less common but can include significant systemic reactions or organ-specific toxicities.

What prior FDA approvals exist?

FDA approvals for treatments in healthy subjects generally involve investigational drugs undergoing initial clinical trials to assess safety, tolerability, pharmacokinetics, and pharmacodynamics. These trials are crucial for preventive treatments and vaccines, which are first tested in healthy volunteers. The approval process includes multiple phases, starting with Phase I to determine safety and dosage, followed by Phase II and III to evaluate efficacy and monitor adverse reactions.

What other types of research exist?

Promising novel alternatives to AZD4144 for healthy subjects in 2024 could include other investigational drugs undergoing early-phase clinical trials that assess safety, tolerability, pharmacokinetics, and pharmacodynamics. Specific alternatives are not detailed in the provided context, but drugs in similar studies would be appropriate candidates.

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AZD4144 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

Females must have a negative pregnancy test, must not be lactating and must be of non-childbearing potential

Have a BMI between 18 and 32 kg/m2 inclusive at both Screening and Admission and weigh at least 45 kg at Screening

Must not have

Any cardiac abnormalities

Previous bone marrow transplant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up part a: day 1 to day 4 and day 10; part b: day -1, day 1 to day 4, day 12 to day 15 and day 20

Summary

This trial tests a new oral drug, AZD4144, in healthy people, including Japanese and Chinese groups. Researchers aim to see how safe it is and how it behaves in the body.

Who is the study for?

This trial is for healthy adults with a BMI of 18-32 and weight over 45 kg. Women must not be pregnant or nursing, and participants should have no history of significant illness that could affect drug absorption or pose risks. Specific cohorts include Chinese individuals who haven't lived outside China for over 10 years, and Japanese participants including second/third generation descendants.

What is being tested?

The study tests AZD4144's safety and how the body reacts to it when taken orally in different doses. It involves giving either the actual drug (AZD4144) or a placebo to healthy volunteers in separate parts (Part A & B), comparing effects between single doses and multiple doses over time.

What are the potential side effects?

While specific side effects are not listed, common reactions may include issues at the site where the drug is administered, general discomforts like headaches or nausea, allergic reactions, or other symptoms related to how the body absorbs and processes AZD4144.

Eligibility Criteria

Inclusion Criteria

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

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I am not pregnant, not breastfeeding, and cannot become pregnant.

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My BMI is between 18 and 32, and I weigh at least 45 kg.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have heart problems.

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I have had a bone marrow transplant.

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I am showing signs and symptoms that could be COVID-19.

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I do not have any serious ongoing infections.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ part a: day 1 to day 4 and day 10; part b: day -1, day 1 to day 4, day 12 to day 15 and day 20

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~part a: day 1 to day 4 and day 10; part b: day -1, day 1 to day 4, day 12 to day 15 and day 20

This trial's timeline: 3 weeks for screening, Varies for treatment, and part a: day 1 to day 4 and day 10; part b: day -1, day 1 to day 4, day 12 to day 15 and day 20 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 (AEs)

Secondary study objectives

Area under plasma concentration-time curve from zero to infinity (AUC0-inf)

Area under the plasma concentration-curve from zero to the last quantifiable concentration (AUClast)

Maximum observed plasma (peak) drug concentration (Cmax)

+2 more

Trial Design

18Treatment groups

Experimental Treatment

Placebo Group

Group I: Part B2 (healthy Japanese participants) Cohort 1Experimental Treatment1 Intervention

Participants will receive one multiple ascending dose of AZD4144.

Group II: Part B1 (healthy participants) Cohort 3Experimental Treatment1 Intervention

Participants will receive one multiple ascending dose of AZD4144.

Group III: Part B1 (healthy participants) Cohort 2Experimental Treatment1 Intervention

Participants will receive one multiple ascending dose of AZD4144.

Group IV: Part B1 (healthy participants) Cohort 1Experimental Treatment1 Intervention

Participants will receive one multiple ascending dose of AZD4144.

Group V: Part A3 (healthy Chinese participants) Cohort 1Experimental Treatment1 Intervention