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

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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

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