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AZD4144 Safety Study in Healthy Subjects

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

Females of non-childbearing potential must be confirmed at the Screening Visit

Females of childbearing potential must not be lactating and if heterosexually active must agree to use an approved method of highly effective contraception

Must not have

Known history of primary immunodeficiency (congenital or acquired) or an underlying condition that predisposes to infection

Clinically significant serious active and chronic infections

Timeline

Screening 3 weeks

Treatment Varies

Follow Up treatment period 1: day 1 to 3; treatment period 2: day 10 to 12.

Summary

This trial will have three parts. Parts A and B will compare the safety, tolerance, and how the drug moves through the body of AZD4144 with a placebo in healthy participants. Part C

Who is the study for?

This trial is for healthy individuals who can participate in a three-part study. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and not have conditions that could interfere with the study or pose risks.

What is being tested?

The trial tests AZD4144's safety, tolerability, how it's processed by the body (pharmacokinetics), and its effects on the body (pharmacodynamics) compared to a placebo. It also examines if AZD4144 affects how rosuvastatin, a cholesterol medication, works when both drugs are taken together.

What are the potential side effects?

Potential side effects aren't specified but generally may include reactions at the injection site, nausea, headaches or other common drug-related adverse events. The impact of AZD4144 on rosuvastatin will be closely monitored for any unexpected interactions.

Eligibility Criteria

Inclusion Criteria

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

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

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

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My BMI is between 18 and 32, and I weigh at least 45 kg.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a condition that makes me more likely to get infections.

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I do not have any serious ongoing infections.

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I have a history of tuberculosis.

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I am showing signs and symptoms that could be COVID-19.

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I am not using any drugs that affect enzyme activity or hormonal contraceptives.

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I don't have any conditions that affect how my body handles medicine.

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I have a history of heavy alcohol use or I currently smoke or use nicotine products.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ part a: day 1 to 3; part b: day 1, 12 and 20+3

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~part a: day 1 to 3; part b: day 1, 12 and 20+3

This trial's timeline: 3 weeks for screening, Varies for treatment, and part a: day 1 to 3; part b: day 1, 12 and 20+3 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast) (Part C)

Area under plasma concentration-time curve from time 0 to infinity (AUCinf) (Part C)

Maximum observed drug concentration (Cmax) (Part C)

+1 more

Secondary study objectives

AUCinf (Part A)

AUClast (Part A and Part B)

Area under concentration-time curve in the dosing interval (AUCτ) (Part B only)

+4 more

Trial Design

17Treatment groups

Experimental Treatment

Placebo Group

Group I: Part C cohort- Treatment C2Experimental Treatment1 Intervention

Participants will receive rosuvastatin and AZD4144.

Group II: Part C Cohort- Treatment C1Experimental Treatment1 Intervention

Participants will receive Rosuvastatin.

Group III: Part B2- Japanese CohortExperimental Treatment1 Intervention

Participants will receive multiple ascending doses of AZD4144.

Group IV: Part B1- Cohort 3Experimental Treatment1 Intervention

Participants will receive multiple ascending doses of AZD4144.

Group V: Part B1- Cohort 2Experimental Treatment1 Intervention

Participants will receive multiple ascending doses of AZD4144.

Group VI: Part B1- Cohort 1Experimental Treatment1 Intervention

Participants will receive multiple ascending doses of AZD4144.

Group VII: Part A3-Chinese CohortExperimental Treatment1 Intervention