AZD1613 for Healthy Subjects

Overseen By AstraZeneca Clinical Study Information Center

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: AstraZeneca

Must not be taking: Antacids, Analgesics, Herbal remedies

Disqualifiers: Gastrointestinal, Hepatic, Renal, others

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

Compensation: Varies

Number of Visits: 270

136 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess the safety and tolerability of AZD1613, an experimental treatment, in healthy individuals, including those of Japanese and Chinese descent. It will also examine how the body processes the drug (pharmacokinetics) and how the drug affects the body (pharmacodynamics). Participants will receive either a single or multiple doses of AZD1613 through injection or infusion. Ideal candidates for this trial are healthy individuals with no significant medical history or ongoing conditions. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

Yes, you will need to stop taking most medications, including prescribed and non-prescribed ones, two weeks before the trial starts. This includes things like antacids, pain relievers (except paracetamol/acetaminophen), and herbal remedies.

Is there any evidence suggesting that AZD1613 is likely to be safe for humans?

Research is testing how well AZD1613 is tolerated by healthy individuals, including those of Japanese and Chinese descent. The study examines both single and multiple doses of AZD1613, administered either as a shot under the skin or through an IV drip.

As a Phase 1 trial, the main focus is on safety. Early trials like this aim to determine if a treatment is safe for humans. Specific information on AZD1613's tolerance is limited, but being in a Phase 1 trial suggests that serious side effects are not expected to be common. If the treatment caused major issues, it likely wouldn't continue in clinical testing.

Participants in this study help researchers learn more about the safety of AZD1613 and any side effects it might cause. This information is essential before testing the treatment in larger groups or for specific conditions. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

AZD1613 is unique because it explores multiple delivery methods, including both subcutaneous (SC) injections and intravenous (IV) infusions, which can provide flexibility in treatment administration. This diversity in delivery options could potentially make it more convenient for patients compared to existing treatments that might only offer one method. Researchers are excited about AZD1613 because it may offer a new mechanism of action or active ingredient that could enhance treatment effectiveness for certain conditions. This trial aims to understand the safety and dosing parameters better, potentially paving the way for more personalized and effective treatment strategies.

What evidence suggests that this trial's treatments could be effective?

Researchers are studying AZD1613 to assess its safety and how the body processes it. In this trial, participants receive varying doses of AZD1613, either as a single dose or multiple doses, through subcutaneous injection or intravenous infusion. Currently, there is no specific information on its effectiveness for any condition, as it is being tested in healthy individuals. The primary goal is to understand the body's tolerance, absorption, and breakdown of the treatment. Researchers are concentrating on safety and potential side effects. If AZD1613 proves well-tolerated, future tests may explore its use in treating diseases. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for healthy adults with good veins for blood draws, not pregnant or able to become pregnant. Men must use contraception. Participants need a BMI of 18-32 and weigh at least 50 kg. Specific parts of the study require participants to be of Chinese or Japanese descent, with both parents and all grandparents being from the same descent.

Inclusion Criteria

My BMI is between 18 and 32, and I weigh at least 50 kg.

I am of Chinese descent with both parents and all four grandparents also being Chinese.

I am of Japanese descent with both parents and all four grandparents also being Japanese.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment (Part A - SAD)

Participants receive a single subcutaneous (SC) or intravenous (IV) dose of AZD1613 or placebo

1 day

1 visit (in-person)

Follow-up (Part A - SAD)

Participants are monitored for safety and effectiveness after treatment

15 weeks

Non-residential visits until Day 105

Treatment (Part B - MAD)

Participants receive multiple doses of AZD1613 or placebo at 28-day intervals

8 weeks

3 visits (in-person) on Days 1, 29, and 57

Follow-up (Part B - MAD)

Participants are monitored for safety and effectiveness after treatment

15 weeks

Non-residential visits until Day 161

What Are the Treatments Tested in This Trial?

Interventions

• AZD1613

Trial Overview

The study is testing AZD1613, a new drug, in healthy people to see how safe it is and how the body reacts to it (pharmacokinetics and pharmacodynamics). It also checks if the body creates any immune response against it (immunogenicity). Some will get AZD1613; others will get a placebo without active ingredients.

How Is the Trial Designed?

Group I: Part B (MAD): AZD1613 (Dose 12) IV Experimental Treatment 2 Interventions

Participants will receive multiple doses of AZD1613 (Dose 12) or matching placebo to AZD1613 as an IV infusion on Days 1, 29 and 57.

Group II: Part B (MAD): AZD1613 (Dose 11) SC Experimental Treatment 2 Interventions

Participants will receive multiple doses of AZD1613 (Dose 11) or matching placebo to AZD1613 as SC injection or IV infusion on Days 1, 29 and 57.

Group III: Part B (MAD): AZD1613 (Dose 10) SC Experimental Treatment 2 Interventions

Participants will receive multiple doses of AZD1613 (Dose 10) or matching placebo to AZD1613 as SC injection or IV infusion on Days 1, 29 and 57.

Group IV: Part A3 (SAD): AZD1613 (Dose 9) SC or IV (Japanese) Experimental Treatment 2 Interventions

Japanese participants will receive a single dose of AZD1613 (Dose 9) or matching placebo to AZD1613 as SC injection or IV infusion on Day 1.

Group V: Part A3 (SAD): AZD1613 (Dose 8) SC or IV (Japanese) Experimental Treatment 2 Interventions

Japanese participants will receive a single dose of AZD1613 (Dose 8) or matching placebo to AZD1613 as SC injection or IV infusion on Day 1.

Group VI: Part A2 (SAD): AZD1613 (Dose 7) SC or IV (Chinese) Experimental Treatment 2 Interventions

Chinese participants will receive a single dose of AZD1613 (Dose 7) or matching placebo to AZD1613 as SC injection or IV infusion on Day 1.

Group VII: Part A1 (SAD): AZD1613 (Dose 6) IV Experimental Treatment 2 Interventions

Participants will receive a single dose of AZD1613 (Dose 6) or matching placebo to AZD1613 as an IV infusion on Day 1.

Group VIII: Part A1 (SAD): AZD1613 (Dose 5) IV Experimental Treatment 2 Interventions

Participants will receive a single dose of AZD1613 (Dose 5) or matching placebo to AZD1613 as an IV infusion on Day 1.

Group IX: Part A1 (SAD): AZD1613 (Dose 4) SC Experimental Treatment 2 Interventions

Participants will receive a single dose of AZD1613 (Dose 4) or matching placebo to AZD1613 as SC injection on Day 1.

Group X: Part A1 (SAD): AZD1613 (Dose 3) SC Experimental Treatment 2 Interventions

Participants will receive a single dose of AZD1613 (Dose 3) or matching placebo to AZD1613 as SC injection on Day 1.

Group XI: Part A1 (SAD): AZD1613 (Dose 2) SC Experimental Treatment 2 Interventions

Participants will receive a single dose of AZD1613 (Dose 2) or matching placebo to AZD1613 as SC injection on Day 1.

Group XII: Part A1 (SAD): AZD1613 (Dose 1) SC Experimental Treatment 2 Interventions

Participants will receive a single dose of AZD1613 (Dose 1) or matching placebo to AZD1613 as SC injection on Day 1.

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

Parexel

Industry Sponsor

Trials

322

Recruited

137,000+

Peyton Howell

Parexel

Chief Executive Officer

Master of Healthcare Administration from The Ohio State University, Bachelor of Arts in Health Communications from the University of Illinois

Dr. Austin Smith

Parexel

Chief Medical Officer since 2023

MD from the Royal College of Surgeons in Ireland

Citations

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clinicaltrials.gov/study/NCT06995820

NCT06995820 | A Study to Investigate Safety, Tolerability ...

Participants will receive multiple doses of AZD1613 (Dose 10) or matching placebo to AZD1613 as SC injection or IV infusion on Days 1, 29 and 57. Intervention/ ...

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withpower.com/trial/phase-1-healthy-subjects-hs-5-2025-78c33

AZD1613 for Healthy Subjects

This Phase 1 medical study run by AstraZeneca is evaluating whether AZD1613 will have tolerable side effects & efficacy for patients with Healthy Subjects.

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A study to investigate safety, tolerability, pharmacokinetics ...

The purpose of the study is to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of AZD1613 in healthy ...

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A Study to Investigate Safety, Tolerability, Pharmacokinetics ...

The purpose of the study is to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of AZD1613 in he...

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AstraZeneca's Phase I Trial of AZD1613: A Potential Game- ...

' The study aims to evaluate the safety and tolerability of AZD1613, a new drug, in healthy individuals, including those of Japanese and Chinese ...

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Safety, tolerability and pharmacokinetics of AZD1613 in adults ...

This Phase I, randomised, single-blind, placebo-controlled study will assess the safety and tolerability of AZD1613 and characterise the ...