What is the mechanism of action of this treatment?

In safety and tolerability studies like the one for AZD1163, treatments are often evaluated for their impact on healthy subjects to ensure they do not cause significant adverse effects. These treatments usually target specific biological pathways or receptors to achieve therapeutic effects. For example, they may inhibit enzymes, block receptors, or modulate immune responses. This is crucial for predicting potential side effects and ensuring the safety of the drug before it is tested in patients with specific conditions. Understanding these mechanisms helps in designing safer and more effective drugs.

What side effects are associated with this type of intervention?

In studies assessing the safety and tolerability of treatments in healthy subjects, common side effects include fatigue, headache, and increased liver enzymes. For instance, in the trial of AZD1163, the focus is on safety and tolerability, which typically involves monitoring for adverse events such as fatigue, headache, and changes in liver enzyme levels. These side effects are generally mild to moderate in severity and often resolve spontaneously or after discontinuation of the treatment.

What prior FDA approvals exist?

FDA approvals for treatments in healthy subjects often involve initial safety and tolerability studies similar to the trial for AZD1163. These studies are designed to assess the safety profile, potential side effects, and pharmacokinetics of new drugs in a controlled environment. While specific drugs similar to AZD1163 are not detailed, this phase is crucial for identifying any immediate adverse reactions and ensuring the drug's safety before it is tested in patients with the target condition. This process helps in determining appropriate dosing and identifying any potential risks early in the drug development process.

What other types of research exist?

Promising novel alternatives to AZD1163 for healthy subjects in 2024 include Diroximel Fumarate, which has demonstrated improved gastrointestinal tolerability in multiple sclerosis patients, and new tyrosine kinase inhibitors like vatalanib, which are being evaluated for their safety and efficacy in various clinical trials. Additionally, the ATM inhibitor AZD0156 is being studied for its potential to enhance the efficacy of other treatments, indicating its promise in future therapeutic applications.

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AZD1163 Safety and Tolerability 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

All females must have a negative pregnancy test

BMI between 18 and 32 kg/m^2 and weigh at least 45 kg

Must not have

Current or recurrent disease of clinical significance

History of latent or active tuberculosis (TB) or exposure to endemic areas

Timeline

Screening 3 weeks

Treatment Varies

Follow Up part 1: days 1-8, 11, 15, 22, 29, 57, 113, 225, 281, 365, 450; part 2: days 1-8, 11, 14-16, 22, 29, 57, 113, 225, 281, 365, 450

Summary

This trial tests a new drug, AZD1163, in healthy people to see if it is safe and well-tolerated. The drug is given either through a vein or under the skin in different doses. The goal is to check for side effects and determine the best way to administer it.

Who is the study for?

Healthy adults with suitable veins for IV use, a BMI of 18-32 kg/m^2, and weighing at least 45 kg can join. Women must test negative for pregnancy and not be breastfeeding; sexually active women need effective contraception. Exclusions include recent drug trials, cancer history (except certain types), abnormal lab results, infectious diseases like hepatitis or HIV, heart ECG issues, significant health risks as per study criteria, recent serious infections or fever, substance abuse history, severe allergies.

What is being tested?

The trial is testing the safety and tolerability of AZD1163 given through an IV or as a shot under the skin in healthy people. Participants will either receive AZD1163 or a placebo to compare effects.

What are the potential side effects?

Since this is a study on healthy volunteers to assess safety and tolerability of AZD1163, specific side effects are being investigated but are not yet known. Common side effects may include reactions at the injection site such as pain or swelling.

Eligibility Criteria

Inclusion Criteria

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

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I am not 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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My condition is currently significant or has come back.

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I have been exposed to or had tuberculosis.

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I tested positive for Covid-19 or had it within the last 4 weeks, or I am experiencing long-term effects.

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I have been treated with a new drug not yet widely available.

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I have no cancer history except for cervical cancer or non-melanoma skin cancer.

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I have active TB or my latent TB was not properly treated.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ part 1: days 1-8, 11, 15, 22, 29, 57, 113, 225, 281, 365, 450; part 2: days 1-8, 11, 14-16, 22, 29, 57, 113, 225, 281, 365, 450

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~part 1: days 1-8, 11, 15, 22, 29, 57, 113, 225, 281, 365, 450; part 2: days 1-8, 11, 14-16, 22, 29, 57, 113, 225, 281, 365, 450

This trial's timeline: 3 weeks for screening, Varies for treatment, and part 1: days 1-8, 11, 15, 22, 29, 57, 113, 225, 281, 365, 450; part 2: days 1-8, 11, 14-16, 22, 29, 57, 113, 225, 281, 365, 450 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

Apparent total body clearance of drug from plasma after extravascular administration (CL/F)

Area under plasma concentration-time curve from zero extrapolated to infinity (AUCinf)

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

+3 more

Trial Design

17Treatment groups

Active Control

Placebo Group

Group I: Part 1 Cohort 5a SADActive Control1 Intervention