AZD4076 for Healthy Male Subjects

Age: 18 - 65

Sex: Male

Trial Phase: Phase 1

Sponsor: AstraZeneca

Must not be taking: Antacids, Analgesics, Herbal remedies, others

Disqualifiers: Hepatic disease, Renal disease, Neurological disease, Psychiatric disease, Drug abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the safety and tolerability of the new drug AZD4076 at various doses. Researchers are testing this drug in humans for the first time and are examining how the body processes it. Healthy males with a stable weight between 50 kg and 100 kg and no major health issues may qualify for this study. Participants will fast for a specified period before and after taking the drug or a placebo (a dummy treatment) to observe its effects on their bodies. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Do I have to stop taking my current medications for the trial?

Yes, you will need to stop taking any prescribed or non-prescribed medications, including herbal remedies and certain vitamins, for two weeks before the trial starts.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that AZD4076 is being tested for safety in healthy male volunteers. As this is the first human trial, limited information exists on how well people tolerate it. Early trials aim to determine how the body processes the drug and identify any side effects.

In this early phase, the treatment remains under close safety monitoring. The focus is on assessing the treatment's safety and identifying any negative effects. Participants in this study will help researchers gain a better understanding of the treatment's safety.

If the drug progresses to later phases, early results likely indicate it is generally well-tolerated at the tested doses. Until then, the focus remains on gathering more detailed safety information. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

AZD4076 is unique because it uses a novel compound, tetracosasodium, which is not found in current treatments for its target condition. Unlike the standard of care, which often involves more conventional mechanisms, AZD4076 may offer a new way to address the condition by potentially targeting different pathways or biological processes. Researchers are excited about this treatment because it could provide an alternative option with possibly fewer side effects or increased efficacy, paving the way for more personalized and effective treatments in the future.

What evidence suggests that AZD4076 could be effective?

AZD4076 is a new treatment tested in healthy men to assess how the body processes it and to evaluate its safety. The trial involves multiple cohorts, with participants receiving either a single dose of AZD4076 or a placebo. This marks the first human trial of the drug, so information on its effectiveness for specific illnesses is limited. The main goal is to understand the drug's behavior in the body and ensure it causes no harm. Early studies like this are crucial for gaining insights into a drug before determining its potential to treat diseases. As research progresses, a clearer understanding of how AZD4076 might aid certain conditions will emerge. ^{1 2 3 5 6}

Who Is on the Research Team?

Ronald Goldwater, MDCM, M.Sc, CPI

Principal Investigator

PAREXEL Early Phase Clinical Unit Baltimore

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have signed and agreed to participate in genetic research.

Provision of signed and dated, written informed consent prior to any study specific procedures

I am a healthy man aged 18-50 with good veins for needle procedures.

Exclusion Criteria

Vulnerable subjects

Severe allergy/hypersensitivity or ongoing clinically significant allergy/hypersensitivity

Excessive intake of caffeine containing drinks or food

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single ascending dose of AZD4076 tetracosasodium or placebo

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

16 weeks

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• AZD4076
• Placebo

Trial Overview 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.

How Is the Trial Designed?

Group I: Cohort 6 Experimental Treatment 2 Interventions

Subjects will be fasted for at least 10 hours before dosing and until 4 hours after dosing of a single dose of AZD4076 tetracosasodium or placebo (high doses may be fractionated)

Group II: Cohort 5 Experimental Treatment 2 Interventions

Subjects will be fasted for at least 10 hours before dosing and until 4 hours after dosing of a single dose of AZD4076 tetracosasodium or placebo (high doses may be fractionated)

Group III: Cohort 4 Experimental Treatment 2 Interventions

Subjects will be fasted for at least 10 hours before dosing and until 4 hours after dosing of a single dose of AZD4076 tetracosasodium or placebo (high doses may be fractionated)

Group IV: Cohort 3 Experimental Treatment 2 Interventions

Subjects will be fasted for at least 10 hours before dosing and until 4 hours after dosing of a single dose of AZD4076 tetracosasodium or placebo (high doses may be fractionated)

Group V: Cohort 2 Experimental Treatment 2 Interventions

Subjects will be fasted for at least 10 hours before dosing and until 4 hours after dosing of a single dose of AZD4076 tetracosasodium or placebo (high doses may be fractionated)

Group VI: Cohort 1 Experimental Treatment 2 Interventions

Subjects will be fasted for at least 10 hours before dosing and until 4 hours after dosing of a single dose of AZD4076 tetracosasodium or placebo (high doses may be fractionated)

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Citations

1. clinicaltrials.gov clinicaltrials.gov/ct2/keydates/NCT02612662

A Study to Assess the Safety and Tolerability of Single Doses ... A phase of research to describe clinical trials that focus on the safety of a drug. They are usually conducted with healthy volunteers, and the goal is to ...

2. astrazenecaclinicaltrials.com astrazenecaclinicaltrials.com/study/D5590C00001

A study to assess the safety and tolerability of single doses ... This is a first-in-human (FIH) study designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of AZD4076 tetracosasodium in healthy male ...

3. plpl.www.astrazenecaclinicaltrials.com plpl.www.astrazenecaclinicaltrials.com/study/D5590C00001

A study to assess the safety and tolerability of single doses ... A study to assess the safety and tolerability of single doses of AZD4076 in healthy male subjects. Study identifier:D5590C00001.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02612662

NCT02612662 | A Study to Assess the Safety and ... This is a first-in-human (FIH) study designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of AZD4076 tetracosasodium in healthy male ...

5. withpower.com withpower.com/trial/phase-1-fatty-liver-10-2015-9fecd

AZD4076 for Healthy Male Subjects · Info for Participants This Phase 1 medical study run by AstraZeneca needs participants to evaluate whether AZD4076 and Placebo will have tolerable side effects & efficacy for ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02826525

NCT02826525 | AZD4076 in Type 2 Diabetic Subjects With ... Subjects participating in this study are adult males and females of non-child bearing potential, who are 18-70 years of age, body mass index 23-40 kg/m2, ...