AZD4954 for Healthy Subjects

Recruiting at 4 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: AstraZeneca

Must not be taking: St John's Wort

Disqualifiers: Gastrointestinal, Hepatic, Renal, others

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

Compensation: Varies

Number of Visits: 2

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and tolerability of a new drug, AZD4954, in healthy individuals. It aims to understand the drug's behavior and effects in the body with single or multiple doses. The study is open to healthy individuals with normal plasminogen levels, and part of the trial requires participants with elevated Lipoprotein(a) levels, a type of protein in the blood. Participants should not have significant health issues that might affect drug absorption or processing. 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?

The trial information does not specify if you need to stop taking your current medications. However, you should avoid drugs with enzyme-inducing properties, like St John's Wort, within 3 weeks before starting the study.

Is there any evidence suggesting that AZD4954 is likely to be safe for humans?

Research has shown that AZD4954 is being tested for safety and tolerability. This study is in the first phase, focusing on determining the treatment's safety for humans and identifying potential side effects.

Participants in studies like this might experience side effects, though the specifics are not always known. In a Phase 1 study, researchers closely monitor any side effects to ensure they remain manageable. The treatment is administered in varying doses to observe the body's reactions, helping researchers assess any risks.

If AZD4954 proves safe at this stage, it may proceed to further testing. This would indicate it is generally well-tolerated, but it is important to remember that findings from this early phase are just the beginning of understanding a new treatment's safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about AZD4954 because it offers a potentially novel approach by targeting pathways not addressed by current treatments. Unlike standard treatments, which may include therapies like beta-blockers or ACE inhibitors for cardiovascular conditions, AZD4954 might work through a unique mechanism of action. This uniqueness could lead to more effective management of the condition, possibly with fewer side effects or a faster onset of action. Moreover, its potential variability in dosing and the effect of food on its absorption are being explored, which could optimize its use in different patient populations.

What evidence suggests that AZD4954 could be effective for elevated Lipoprotein(a) levels?

Research has shown that AZD4954 might help lower Lipoprotein(a), a type of cholesterol linked to heart disease. Animal studies found that this drug effectively reduces these cholesterol levels by affecting certain processes in the body that control cholesterol production. Early results from healthy volunteers suggest that AZD4954 is safe and may lower Lipoprotein(a) in people. However, more research is needed to confirm these effects in a larger group. Participants in this trial will receive different doses of AZD4954 or a placebo to further evaluate its safety and efficacy. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for healthy adults, some with high levels of a cholesterol particle called Lipoprotein(a) or Lp(a). Participants should not have any significant health issues and must meet specific criteria set by the study.

Inclusion Criteria

Participants with plasminogen level within normal range at the Screening Visit

I am a woman who cannot become pregnant, confirmed at my screening visit.

I have tested negative for pregnancy before starting the trial.

Exclusion Criteria

I have a history of a significant health condition.

I have a bleeding or clotting disorder.

Any clinically important abnormalities in hematology, coagulation, clinical chemistry, urinalysis, abnormal vital signs or abnormal laboratory values

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 dose of AZD4954 or placebo and are monitored for 15 days

2 weeks

Daily monitoring at the study site

Follow-up (Part A - SAD)

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 follow-up visit

Treatment (Part B - MAD)

Participants receive multiple doses of AZD4954 or placebo for 21 days (14 days for Japanese cohorts)

3 weeks

Daily monitoring at the study site

Follow-up (Part B - MAD)

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 follow-up visit

What Are the Treatments Tested in This Trial?

Interventions

• AZD4954

Trial Overview

The study tests AZD4954 against a placebo to see how safe it is and how the body reacts to it. It will look at different doses given once or over multiple times in people with normal or high Lp(a) levels.

How Is the Trial Designed?

Group I: Part B: Optional Global MAD Cohort 4 - AZD4954 Experimental Treatment 2 Interventions

Participants will receive multiple doses of AZD4954 or matching placebo for 21 days. This additional cohort may be added depending on the findings.

Group II: Part B: MAD Cohort (Japanese) - AZD4954 (Dose 3) Experimental Treatment 2 Interventions

Japanese participants will receive multiple doses of AZD4954 (Dose 3) or matching placebo for 14 days.

Group III: Part B: Global MAD Cohort 3 - AZD4954 (Dose 3) Experimental Treatment 2 Interventions

Participants will receive multiple doses of AZD4954 (Dose 3) or matching placebo for 21 days.

Group IV: Part B: Global MAD Cohort 2 - AZD4954 (Dose 2) Experimental Treatment 2 Interventions

Participants will receive multiple doses of AZD4954 (Dose 2) or matching placebo for 21 days.

Group V: Part B: Global MAD Cohort 1 - AZD4954 (Dose 1) Experimental Treatment 2 Interventions

Participants will receive multiple doses of AZD4954 (Dose 1) or matching placebo for 21 days.

Group VI: Part A2: SAD Food Effect Cohort - AZD4954 (Dose 2) Experimental Treatment 2 Interventions

Participants will receive a single dose of AZD4954 (Dose 2) or matching placebo with a high-calorie, high-fat breakfast on Day 1.

Group VII: Part A1: SAD Optional Cohort 6 - AZD4954 (Dose 6) Experimental Treatment 2 Interventions

Participants will receive a single dose of AZD4954 (Dose 6) or matching placebo on Day 1. This additional cohort may be added depending on the findings.

Group VIII: Part A1: SAD Optional Cohort 3 (Japanese) - AZD4954 Experimental Treatment 2 Interventions

This additional cohort may be added depending on the findings.

Group IX: Part A1: SAD Cohort 5 - AZD4954 (Dose 5) Experimental Treatment 2 Interventions

Participants will receive a single dose of AZD4954 (Dose 5) or matching placebo on Day 1.

Group X: Part A1: SAD Cohort 4 - AZD4954 (Dose 4) Experimental Treatment 2 Interventions

Participants will receive a single dose of AZD4954 (Dose 4) or matching placebo on Day 1.

Group XI: Part A1: SAD Cohort 3 - AZD4954 (Dose 3) Experimental Treatment 2 Interventions

Participants will receive a single dose of AZD4954 (Dose 3) or matching placebo on Day 1.

Group XII: Part A1: SAD Cohort 2 - AZD4954 (Dose 2) Experimental Treatment 2 Interventions

Participants will receive a single dose of AZD4954 (Dose 2) or matching placebo on Day 1.

Group XIII: Part A1: SAD Cohort 2 (Japanese) - AZD4954 (Dose 3) Experimental Treatment 2 Interventions

Japanese participants will receive a single dose of AZD4954 (Dose 3) or matching placebo on Day 1.

Group XIV: Part A1: SAD Cohort 1 - AZD4954 (Dose 1) Experimental Treatment 2 Interventions

Participants will receive a single dose of AZD4954 (Dose 1) or matching placebo on Day 1.

Group XV: Part A1: SAD Cohort 1 (Japanese) - AZD4954 (Dose 2) Experimental Treatment 2 Interventions

Japanese participants will receive a single dose of AZD4954 (Dose 2) or matching placebo on Day 1.

Group XVI: Part A1: SAD Cohort 1 (Chinese) - AZD4954 (Dose 5) Experimental Treatment 2 Interventions

Chinese participants will receive a single dose of AZD4954 (Dose 5) or matching placebo at the highest dose level 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

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06980428

NCT06980428 | A Study to Investigate Safety, Tolerability ...

A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD4954 in Healthy Adult Participants With or Without Elevated ...

2.

astrazenecaclinicaltrials.com

astrazenecaclinicaltrials.com/study/D7300C00001

A Study to Investigate Safety, Tolerability ...

A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD4954 in Healthy Adult Participants with or without Elevated ...

3.

centerwatch.com

centerwatch.com/clinical-trials/listings/NCT06980428/a-study-to-investigate-safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-azd4954-in-healthy-adult-participants-with-or-without-elevated-lipoprotein-a-lpa-levels

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

A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD4954 in Healthy Adult Participants With or Without Elevated ...

4.

withpower.com

withpower.com/trial/phase-1-healthy-subjects-hs-4-2025-98368

AZD4954 for Healthy Subjects

The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple ascending doses of ...

5.

theglobeandmail.com

theglobeandmail.com/investing/markets/stocks/AZN/pressreleases/33471153/astrazenecas-new-study-on-azd4954-a-potential-game-changer-in-cardiovascular-treatment/

AstraZeneca's New Study on AZD4954: A Potential Game ...

The intervention involves administering AZD4954, an oral drug, to healthy participants with varying doses, alongside a placebo for control.

6.

theglobeandmail.com

theglobeandmail.com/investing/markets/stocks/AZN/pressreleases/34005554/astrazenecas-phase-i-study-on-azd4954-a-potential-game-changer-in-cardiovascular-treatment/

AstraZeneca's Phase I Study on AZD4954: A Potential ...

' The study aims to evaluate the safety and effectiveness of AZD4954 in healthy adults, focusing on those with varying levels of Lipoprotein ...

7.

ainvest.com

ainvest.com/news/astrazeneca-azd4954-promising-treatment-cardiovascular-disease-2508/

AstraZeneca's AZD4954: A Promising New Treatment for ...

The study aims to evaluate the safety and effectiveness of AZD4954 in healthy adults ... The primary goal is to gather initial safety and efficacy ...