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AZD4076 for Healthy Male Subjects

Phase 1

Waitlist Available

Led By Ronald Goldwater, MDCM, M.Sc, CPI

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

BMI between 18 and 30 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive

Be between 18 and 65 years old

Must not have

Use of drugs with enzyme inducing properties

Subjects who cannot communicate reliably with the investigator

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from screening until 16 weeks postdose, up to 5 months

Summary

This trialtests a drug to see if it's safe, tolerated and how it affects the body in healthy males at different doses.

Who is the study for?

Healthy male participants aged 18-50, with a BMI of 18-30 kg/m2 and weighing between 50-100 kg. They must have good veins for blood draws, provide consent, not smoke or use nicotine in the past three months, avoid certain medications before the trial, and not donate plasma or significant amounts of blood recently.

What is being tested?

The study is testing AZD4076 tetracosasodium's safety and how it's processed by the body at different doses compared to a placebo. It's a first-in-human study involving healthy men who will receive single increasing doses to assess tolerability.

What are the potential side effects?

Since this is an initial test of AZD4076 in humans (first-in-human), specific side effects are unknown but may include typical drug reactions like nausea, headaches, dizziness or allergic responses. Participants will be closely monitored for any adverse effects.

Eligibility Criteria

Inclusion Criteria

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

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My BMI is between 18 and 30, and I weigh between 50kg and 100kg.

Exclusion Criteria

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

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I am not taking medication that affects enzyme activity.

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I can communicate clearly with my doctor.

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I have had a bone marrow transplant.

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I have liver, kidney disease, or a condition affecting drug metabolism.

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I might have Gilbert's syndrome according to my liver tests.

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I haven't taken any medication, prescribed or not, in the last two weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from screening until 16 weeks postdose, up to 5 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from screening until 16 weeks postdose, up to 5 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from screening until 16 weeks postdose, up to 5 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

The safety and tolerability of AZD4076 by assessing clinical chemistry

The safety and tolerability of AZD4076 by assessing hematology

The safety and tolerability of AZD4076 by assessing the injection site

+10 more

Secondary study objectives

AUC assessed for AZD4076 metabolites from the plasma data

Brain Diseases, Metabolic

AUC(0-last) assessed forAZD4076 metabolites from the plasma data

+29 more