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

32 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will assess the safety, tolerability and pharmacokinetics (PK) of AZD0292 following intravenous (IV) administration of single ascending doses to healthy adult participants.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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