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Part A (SAD): Cohort 1A - AZD0233 (dose 1) for Dilated Cardiomyopathy

Phase 1

Recruiting

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit

Have a body mass index between 18 and 30 kg/m² inclusive and weigh at least 50 kg

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 (pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 hours), day 2 (24 hours and 36 hours post-dose) and day 3 (48 hours post-dose)

Awards & highlights

Study Summary

"This trial aims to test the safety, side effects, and how the body processes AZD0233 in healthy volunteers after receiving different doses of the medication."

Who is the study for?

Healthy adults, particularly those of Japanese descent with both parents and all grandparents being Japanese. Participants must have a BMI between 18-30 kg/m², weigh at least 50 kg, and suitable veins for blood draws. Women must not be pregnant and men with fertile partners must use contraception. Excludes vegans, those with dietary restrictions or recent minor medical issues that could affect the study.Check my eligibility

What is being tested?

The trial is testing AZD0233's safety and how the body processes it after one or more doses in healthy people compared to a placebo (a substance with no therapeutic effect). It involves taking either the drug or placebo to see what happens in their bodies over time.See study design

What are the potential side effects?

While specific side effects are not listed for AZD0233 as it's under investigation, common side effects from clinical trials can include headaches, nausea, fatigue, reactions at the injection site if applicable, and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have taken a pregnancy test and it was negative.

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My BMI is between 18 and 30, and I weigh at least 50 kg.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 (pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 hours), day 2 (24 hours and 36 hours post-dose) and day 3 (48 hours post-dose)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 (pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 hours), day 2 (24 hours and 36 hours post-dose) and day 3 (48 hours post-dose)

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 (pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 hours), day 2 (24 hours and 36 hours post-dose) and day 3 (48 hours post-dose) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participants with adverse events (AEs) and serious adverse events (SAEs)

Secondary outcome measures

Accumulation ratio for AUC (Rac AUC) of AZD0233

Accumulation ratio for Cmax (Rac Cmax) of AZD0233

Apparent total body clearance of drug from plasma after extravascular administration (CL/F) of AZD0233

+12 more

Trial Design

11Treatment groups

Experimental Treatment

Placebo Group

Group I: Part B (MAD): Cohort 3B - AZD0233 (dose 8)Experimental Treatment1 Intervention

Healthy participants will receive AZD0233 (dose 8) orally as a multiple ascending dose.

Group II: Part B (MAD): Cohort 2B - AZD0233 (dose 7)Experimental Treatment1 Intervention

Healthy participants will receive AZD0233 (dose 7) orally as a multiple ascending dose.

Group III: Part B (MAD): Cohort 1B - AZD0233 (dose 6)Experimental Treatment1 Intervention

Healthy participants will receive AZD0233 (dose 6) orally as a multiple ascending dose.

Group IV: Part A (SAD): Food Effect (FE) extended Cohort 3AExperimental Treatment1 Intervention

Healthy participants from Cohort 3A will participate in this extended cohort after a washout period of 24 hours.

Group V: Part A (SAD): Cohort 5A - AZD0233 (dose 5)Experimental Treatment1 Intervention

Healthy participants will receive AZD0233 (dose 5) orally as a single ascending dose.

Group VI: Part A (SAD): Cohort 4A - AZD0233 (dose 4)Experimental Treatment1 Intervention

Healthy participants will receive AZD0233 (dose 4) orally as a single ascending dose.

Group VII: Part A (SAD): Cohort 3A - AZD0233 (dose 3)Experimental Treatment1 Intervention

Healthy participants will receive AZD0233 (dose 3) orally as a single ascending dose.

Group VIII: Part A (SAD): Cohort 2A - AZD0233 (dose 2)Experimental Treatment1 Intervention

Healthy participants will receive AZD0233 (dose 2) orally as a single ascending dose.

Group IX: Part A (SAD): Cohort 1A - AZD0233 (dose 1)Experimental Treatment1 Intervention

Healthy participants will receive AZD0233 (dose 1) orally as a single ascending dose.

Group X: Part B (MAD): Placebo cohortPlacebo Group1 Intervention

Healthy participants will receive placebo orally as a multiple ascending dose.

Group XI: Part A (SAD): Placebo cohortPlacebo Group1 Intervention

Healthy participants will receive placebo orally as a single ascending dose.

0 / 2Eligibility criteria met

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

ParexelIndustry Sponsor

304 Previous Clinical Trials

101,056 Total Patients Enrolled

AstraZenecaLead Sponsor

4,274 Previous Clinical Trials

288,613,268 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals aged 65 and above eligible to participate in this research study?

"This clinical investigation is seeking participants aged over 18 and under 50 years old."

Answered by AI

Would it be possible for me to participate in this medical study?

"Candidates eligible for enrollment in this trial should have dilated cardiomyopathy and fall within the age range of 18 to 50 years. A total of 96 participants are sought for inclusion in the study."

Answered by AI

What is the upper limit on the count of participants involved in this study?

"Affirmative. As indicated on clinicaltrials.gov, this investigation is currently seeking suitable candidates. The trial was initially disclosed on April 1st, 2024 and the latest revision occurred on April 19th, 2024. A total of 96 participants are sought from a singular site for enrollment in this study."

Answered by AI

Are potential participants still able to enroll in this ongoing trial?

"Indeed, as per clinicaltrials.gov data, this particular trial is currently in the recruitment phase. Initially listed on April 1st, 2024 and most recently revised on April 19th, 2024, it aims to enroll a total of 96 participants from one specified location."

Answered by AI

What are the risks associated with Part A (SAD): Cohort 1A - AZD0233 (dose 1) for participants?

"In this Phase 1 trial, Part A (SAD): Cohort 1A - AZD0233 (dose 1) received a safety rating of 1 from the Power team due to the scarcity of data backing its safety and efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Investigate Safety, Tolerability, and Pharmacokinetics of Oral AZD0233 Compared With Placebo in Healthy Adult Participants.

2024. "A Study to Investigate Safety, Tolerability, and Pharmacokinetics of Oral AZD0233 Compared With Placebo in Healthy Adult Participants.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06381466.

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