AZD5148 for Healthy Subjects

Recruiting at 3 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: AstraZeneca

Must not be taking: Glucocorticoids, Monoclonal antibodies

Disqualifiers: Hepatitis, HIV, Alcohol/drug abuse, others

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

Compensation: Varies

Number of Visits: 362

Duration: 1 day

84 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. However, since the trial is for healthy participants, it's possible that taking medications could affect eligibility.

What is the purpose of this trial?

The purpose of this study is to measure safety, tolerability, and pharmacokinetics (PK) of a single dose of AZD5148 administered via intravenous (IV) bolus or intramuscular (IM) injection in healthy participants

Eligibility Criteria

Healthy adults with good veins for blood draws can join. Women must not be pregnant, and if they can have children, they need to use birth control. People of Chinese descent must meet specific ancestry criteria. You can't join if you've had a serious illness or surgery recently, any history of cancer (except certain skin/cervical cancers), immune problems including HIV, drug/alcohol abuse, bleeding disorders, are detained or under legal supervision.

Inclusion Criteria

I have veins suitable for repeated needle insertions.

I have taken a pregnancy test and it was negative.

Healthy Chinese participants must meet specific criteria related to Chinese ancestry, birthplace, ancestry of grandparents and parents, duration of living outside China, and lifestyle changes since leaving China

Exclusion Criteria

I haven't had a major illness, surgery, or injury in the last 4 weeks.

I have had no cancers in the past 5 years, except for skin or cervical cancer that was treated locally.

I have not used strong immune-weakening drugs or have HIV.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants receive a single dose of AZD5148 or placebo via IM injection or IV bolus

1 day

Participants will be resident at the Clinical Unit from the day before study drug administration (Day -1) until all assessments are completed on Day 2

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Final Follow-up Visit will occur within 361 ± 14 days after the study drug administration

Treatment Details

Interventions

• AZD5148

Trial Overview The trial is testing AZD5148's safety and how the body processes it after one dose given by IV or IM injection in healthy people. Some will get AZD5148; others will get a placebo (no active drug) to compare results.

Participant Groups

Group I: Cohort 5: AZD5148 (dose 4) IV Experimental Treatment 2 Interventions

Participants will receive AZD5148 (dose 4) or matching placebo as an IV bolus

Group II: Cohort 4b: AZD5148 (dose 3) IV Experimental Treatment 2 Interventions

Participants of Chinese descent will receive AZD5148 (dose 3) or matching placebo as an IV bolus

Group III: Cohort 4a: AZD5148 (dose 3) IV Experimental Treatment 2 Interventions

Participants will receive AZD5148 (dose 3) or matching placebo as an IV bolus

Group IV: Cohort 3: AZD5148 (dose 2) IV Experimental Treatment 2 Interventions

Participants will receive AZD5148 (dose 2) or matching placebo as an IV bolus

Group V: Cohort 2b: AZD5148 (dose 2) IM Experimental Treatment 2 Interventions

Participants of Chinese descent will receive AZD5148 (dose 2) or matching placebo as an IM injection

Group VI: Cohort 2a: AZD5148 (dose 2) IM Experimental Treatment 2 Interventions

Participants will receive AZD5148 (dose 2) or matching placebo as an IM injection

Group VII: Cohort 1: AZD5148 (dose 1) IM Experimental Treatment 2 Interventions

Participants will receive AZD5148 (dose 1) or matching placebo as an IM injection

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