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AZD4144 for 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 must have a negative pregnancy test, must not be lactating and must be of non-childbearing potential

Have a BMI between 18 and 32 kg/m2 inclusive at both Screening and Admission and weigh at least 45 kg at Screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up part a: day 1 to day 4 and day 10; part b: day -1, day 1 to day 4, day 12 to day 15 and day 20

Awards & highlights

Study Summary

This trial will assess the effects and safety of a new drug given to healthy people.

Who is the study for?

This trial is for healthy adults with a BMI of 18-32 and weight over 45 kg. Women must not be pregnant or nursing, and participants should have no history of significant illness that could affect drug absorption or pose risks. Specific cohorts include Chinese individuals who haven't lived outside China for over 10 years, and Japanese participants including second/third generation descendants.Check my eligibility

What is being tested?

The study tests AZD4144's safety and how the body reacts to it when taken orally in different doses. It involves giving either the actual drug (AZD4144) or a placebo to healthy volunteers in separate parts (Part A & B), comparing effects between single doses and multiple doses over time.See study design

What are the potential side effects?

While specific side effects are not listed, common reactions may include issues at the site where the drug is administered, general discomforts like headaches or nausea, allergic reactions, or other symptoms related to how the body absorbs and processes AZD4144.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am not pregnant, not breastfeeding, and cannot become pregnant.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ part a: day 1 to day 4 and day 10; part b: day -1, day 1 to day 4, day 12 to day 15 and day 20

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~part a: day 1 to day 4 and day 10; part b: day -1, day 1 to day 4, day 12 to day 15 and day 20

This trial's timeline: 3 weeks for screening, Varies for treatment, and part a: day 1 to day 4 and day 10; part b: day -1, day 1 to day 4, day 12 to day 15 and day 20 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)

Secondary outcome measures

Area under plasma concentration-time curve from zero to infinity (AUC0-inf)

Area under the plasma concentration-curve from zero to the last quantifiable concentration (AUClast)

Maximum observed plasma (peak) drug concentration (Cmax)

+2 more

Trial Design

18Treatment groups

Experimental Treatment

Placebo Group

Group I: Part B2 (healthy Japanese participants) Cohort 1Experimental Treatment1 Intervention

Participants will receive one multiple ascending dose of AZD4144.

Group II: Part B1 (healthy participants) Cohort 3Experimental Treatment1 Intervention

Participants will receive one multiple ascending dose of AZD4144.

Group III: Part B1 (healthy participants) Cohort 2Experimental Treatment1 Intervention

Participants will receive one multiple ascending dose of AZD4144.

Group IV: Part B1 (healthy participants) Cohort 1Experimental Treatment1 Intervention

Participants will receive one multiple ascending dose of AZD4144.

Group V: Part A3 (healthy Chinese participants) Cohort 1Experimental Treatment1 Intervention