AZD1163 Safety and Tolerability for Healthy Subjects

Recruiting in Palo Alto (17 mi)

+2 other locations

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: AstraZeneca

Disqualifiers: Malignancies, Active infections, TB, others

Trial Summary

What is the purpose of this trial?

This trial tests a new drug, AZD1163, in healthy people to see if it is safe and well-tolerated. The drug is given either through a vein or under the skin in different doses. The goal is to check for side effects and determine the best way to administer it.

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

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Research Team

Eligibility Criteria

Healthy adults with suitable veins for IV use, a BMI of 18-32 kg/m^2, and weighing at least 45 kg can join. Women must test negative for pregnancy and not be breastfeeding; sexually active women need effective contraception. Exclusions include recent drug trials, cancer history (except certain types), abnormal lab results, infectious diseases like hepatitis or HIV, heart ECG issues, significant health risks as per study criteria, recent serious infections or fever, substance abuse history, severe allergies.

Inclusion Criteria

I have veins suitable for repeated needle insertions.

I am not pregnant.

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

Exclusion Criteria

My condition is currently significant or has come back.

I have been exposed to or had tuberculosis.

You have a history of serious allergies or ongoing allergies that could affect your health.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment Part 1 (SAD)

Participants receive a single ascending dose of AZD1163 with an in-clinic period of 7 to 8 days

1-2 weeks

In-clinic stay for 7-8 days

Treatment Part 2 (MAD)

Participants receive multiple ascending doses of AZD1163, given 2 weeks apart, each with an in-clinic period of 7 to 8 days

4 weeks

In-clinic stay for 7-8 days per dose

Follow-up

Participants are monitored for safety and effectiveness after treatment

15 months

Treatment Details

Interventions

• AZD1163 (Other)
• Placebo (Other)

Trial Overview The trial is testing the safety and tolerability of AZD1163 given through an IV or as a shot under the skin in healthy people. Participants will either receive AZD1163 or a placebo to compare effects.

Participant Groups

Group I: Part 1 Cohort 5a SAD Active Control 1 Intervention

Participants will receive IV infusion of AZD1163 on Day 1.

Group II: Part 1 Cohort 9 SAD (Chinese Participants) Active Control 1 Intervention

Participants will receive SC injection of AZD1163 on Day 1.

Group III: Part 2 Cohort 1 MAD (Global) Active Control 1 Intervention

Participants will receive SC injection of AZD1163 on Days 1 and 15.

Group IV: Part 2 Cohort 2 MAD (Global) Active Control 1 Intervention

Participants will receive SC injection of AZD1163 on Days 1 and 15.

Group V: Part 2 Cohort 3 MAD (Chinese Participants) Active Control 1 Intervention

Participants will receive SC injection of AZD1163 on Days 1 and 15.

Group VI: Part 2 Cohort 4 MAD (Japanese participants) Active Control 1 Intervention

Participants will receive SC injection of AZD1163 on Days 1 and 15.

Group VII: Part 1 Cohort 7 SAD Active Control 1 Intervention

Participants will receive IV infusion of AZD1163 on Day 1.

Group VIII: Part 1 Cohort 6 SAD Active Control 1 Intervention

Participants will receive IV infusion of AZD1163 on Day 1.

Group IX: Part 1 Cohort 1 SAD Active Control 1 Intervention

Participants will receive IV infusion of AZD1163 on Day 1.

Group X: Part 1 Cohort 4 SAD Active Control 1 Intervention

Participants will receive IV infusion of AZD1163 on Day 1.

Group XI: Part 1 Cohort 3 SAD Active Control 1 Intervention

Participants will receive IV infusion of AZD1163 on Day 1.

Group XII: Part 1 Cohort 2 SAD Active Control 1 Intervention

Participants will receive IV infusion of AZD1163 on Day 1.

Group XIII: Part 1 Cohort 8 SAD Active Control 1 Intervention

Participants will receive IV infusion of AZD1163 on Day 1.

Group XIV: Part 1 Cohort 5b SAD Active Control 1 Intervention

Participants will receive SC injection of AZD1163 on Day 1.

Group XV: Part 1 Pooled Placebo SAD IV Placebo Group 1 Intervention

Participants will receive matching IV infusion of placebo on Day 1.

Group XVI: Part 1 Placebo SAD SC Placebo Group 1 Intervention

Participants will receive matching SC injection of placebo on Day 1.

Group XVII: Part 1 Placebo SAD (Chinese Participants) Placebo Group 1 Intervention

Participants will receive matching SC injection of placebo on Day 1.

Group XVIII: Part 2 Placebo MAD (Global) Placebo Group 1 Intervention

Participants will receive matching SC injection of placebo on Days 1 and 15.

Group XIX: Part 2 Placebo MAD (Chinese participants) Placebo Group 1 Intervention

Participants will receive matching SC injection of placebo on Days 1 and 15.

Group XX: Part 2 Placebo MAD (Japanese participants) Placebo Group 1 Intervention

Participants will receive matching SC injection of placebo on Days 1 and 15.

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

Parexel

Industry Sponsor

Trials

322

Recruited

137,000+

Peyton Howell

Parexel

Chief Executive Officer

Master of Healthcare Administration from The Ohio State University, Bachelor of Arts in Health Communications from the University of Illinois

Dr. Austin Smith

Parexel

Chief Medical Officer since 2023

MD from the Royal College of Surgeons in Ireland