AZD0292 for Healthy Participants

Overseen By AstraZeneca Clinical Study Information Center

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: AstraZeneca

Must not be taking: Antidepressants, Antipsychotics, others

Disqualifiers: Gastrointestinal, Hepatic, Renal, others

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 explores a new drug, AZD0292, and its effects at different doses. The main goal is to determine its safety and tolerability in healthy participants and to understand how the body processes it. Participants may receive one of three doses of AZD0292 or a placebo, which contains no active drug. Those who are generally healthy, not currently on most medications, and haven't smoked recently might be suitable for this study.

As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

Yes, you will need to stop taking most medications at least 7 days before the study starts, except for contraceptives, hormone replacement therapy, and certain over-the-counter medications like acetaminophen and antihistamines. Vitamins and supplements that you've been taking for at least 30 days are allowed.

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

Research has shown that AZD0292 has been tested in various studies to assess its safety in humans. In one study involving healthy Japanese adults, researchers administered AZD0292 in gradually increasing amounts through an IV (a needle in the vein). This study evaluated the drug's tolerability and safety.

Research also explores the use of AZD0292 in patients with bronchiectasis, a lung condition. These studies examine its long-term safety and effectiveness. Although detailed results are not provided here, testing AZD0292 in healthy individuals suggests it remains in the early stages of research, with full safety details still being gathered.

In these early studies, researchers check for side effects and how the body processes the drug. AZD0292 continues to be closely monitored to ensure its safety for use. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about AZD0292 because it represents a new approach with its unique mechanism of action as an intravenous (IV) infusion, which differs from many current treatments that may be oral or have different delivery methods. This treatment is being explored at multiple doses, allowing researchers to understand its optimal efficacy and safety, which is crucial for personalized medicine. By offering a potentially faster and more targeted way to address the condition, AZD0292 could pave the way for more effective management options.

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

Research is investigating AZD0292 as a potential treatment to prevent flare-ups in individuals with bronchiectasis, a lung condition. This treatment is a specialized protein targeting specific parts of the immune system. Early studies have tested AZD0292 in healthy individuals to assess its safety and how the body processes it. Although detailed information on its effectiveness in patients is limited, its mechanism suggests it might help control lung inflammation. Further studies are necessary to confirm its benefits for patients. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for healthy adults who can participate in a study to test the safety of a new drug. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and have no conflicting conditions.

Inclusion Criteria

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

I have taken a pregnancy test and it was negative.

I am not breastfeeding and agree to use effective birth control if I'm sexually active.

Exclusion Criteria

Any abnormalities in clinical chemistry, hematology, coagulation, or urinalysis results

History of any clinically important disease or disorder which, in the opinion of the principal investigator (PI), may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study

Positive screen for drugs of abuse, alcohol, or cotinine at screening or on admission to the Clinical Unit

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants receive a single ascending dose of AZD0292 or placebo via IV infusion on Day 1

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Multiple visits (in-person)

Extended Follow-up

Participants continue to be monitored for safety and pharmacokinetics

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AZD0292

Trial Overview The trial is testing AZD0292, given through an IV at increasing doses, against a placebo to see how safe it is and how the body processes it. Participants will be randomly assigned to receive either the drug or placebo.

How Is the Trial Designed?

Group I: AZD0292 Dose 3 Experimental Treatment 1 Intervention

Participants will receive single dose of AZD0292 dose 3 as IV infusion on Day 1.

Group II: AZD0292 Dose 2 Experimental Treatment 1 Intervention

Participants will receive single dose of AZD0292 dose 2 as IV infusion on Day 1.

Group III: AZD0292 Dose 1 Experimental Treatment 1 Intervention

Participants will receive single dose of AZD0292 dose 1 as IV infusion on Day 1.

Group IV: Placebo Placebo Group 1 Intervention

Participants will receive matching placebo to AZD0292 as IV infusion 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/NCT07222254

NCT07222254 | A Study to Assess the Safety, Tolerability ... To assess the safety and tolerability of AZD0292 following IV administration of single ascending doses to healthy Japanese adult participants.

2. astrazenecaclinicaltrials.com astrazenecaclinicaltrials.com/study/D7700C00001

A Study to Assess the Safety, Tolerability, and ... This study will assess the safety, tolerability and pharmacokinetics (PK) of AZD0292 following intravenous (IV) administration of single ascending doses to ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07088926

NCT07088926 | A Study to Evaluate the Efficacy, Safety ... AZD0292 is a bispecific IgG1k mAb being evaluated for the prevention of exacerbations in bronchiectasis patients chronically colonized with PsA.

4. withpower.com withpower.com/trial/azd0292-for-healthy-participants-f7f50

AZD0292 for Healthy Participants Trial Overview The trial is testing AZD0292, given through an IV at increasing doses, against a placebo to see how safe it is and how the body processes it.

5. dede.www.astrazenecaclinicaltrials.com dede.www.astrazenecaclinicaltrials.com/study/D7700C00003

A study to evaluate the efficacy, safety, and PK of AZD0292 ... This Phase IIb study aims to assess the efficacy, safety, and PK of 2 dosage regimens of AZD0292 administered IV, as compared to placebo in ...

6. ctv.veeva.com ctv.veeva.com/study/a-study-to-evaluate-the-efficacy-safety-and-pk-of-azd0292-administered-iv-in-participants-12-years

A Study to Evaluate the Efficacy, Safety, and PK of AZD0292 ... AZD0292 is a bispecific IgG1k mAb being evaluated for the prevention of exacerbations in bronchiectasis patients chronically colonized with PsA.

7. theglobeandmail.com theglobeandmail.com/investing/markets/stocks/AZN/pressreleases/35801399/astrazenecas-new-phase-i-study-on-azd0292-key-insights-for-investors/

AstraZeneca's New Phase I Study on AZD0292 ' The study aims to evaluate the safety, tolerability, and pharmacokinetics of AZD0292, a drug administered via intravenous infusion, in healthy ...