A Study to Assess Safety, Tolerability, and Pharmacokinetics of AZD0186

Overseen By AstraZeneca Clinical Study Information Center

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: AstraZeneca

Must not be taking: GLP-1 RA

Disqualifiers: Gastrointestinal, Hepatic, Renal, Retinal, others

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

Compensation: Varies

Number of Visits: 9

Duration: 3 days

31 Participants Needed

Trial Summary

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

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

What is the purpose of this trial?

This trial tests a new drug, AZD0186, on healthy adults to ensure it is safe and understand how the body processes it.

Research Team

Esther Yoon, MD

Principal Investigator

PAREXEL Early Phase Clinical Unit-Los Angeles

Eligibility Criteria

Inclusion Criteria

Provision of signed and dated, written informed consent prior to any study specific procedures.

Provision of signed, written, and dated informed consent for optional genetic/biomarker research.

Have a BMI between: Part 1: 18 to 32 kg/m2 inclusive, Part 2 and Part 3: 18 to 32 kg/m2 inclusive, and weigh at least 50 kg (males and females).

Exclusion Criteria

You have a history or currently have a gastrointestinal, liver, or kidney disease, or any other medical condition that can affect how your body processes drugs.

You have a medical condition that may put you at risk or affect your ability to participate in the study.

You have had retinal detachment in one or both of your eyes in the past.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants receive single ascending doses of AZD0186 and are monitored for safety and pharmacokinetics

3 days

In-residence from Day -2 to Day 3

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

Follow-up visit 7 or 14 days after last dose

Treatment Details

Interventions

• AZD0186
• Placebo

Participant Groups

Group I: Cohort 4 (healthy volunteers - food effect) Experimental Treatment 2 Interventions

One of the Part 1 cohorts (planned for Cohort 6, can be updated pending emerging data) will continue into the food-effect part after a washout period. This part will be initiated after SRC review of all available data from preceding cohorts in this study.

Group II: Cohort 3 (healthy Chinese volunteers) Experimental Treatment 2 Interventions

The planned number of Chinese cohorts is 1, but more than 1 cohort may be included if it is considered necessary to repeat a dose level or if additional dose steps are required. No sentinel dosing will be performed for the Chinese cohort.

Group III: Cohort 2 (healthy Japanese volunteers) Experimental Treatment 2 Interventions

The planned number of Japanese cohorts is 1, but more than 1 cohort may be included if the SRC considers it necessary to repeat a dose level or if additional dose steps are required. No sentinel dosing will be performed for the Japanese cohort.

Group IV: Cohort 1 (healthy volunteers) Experimental Treatment 2 Interventions

The planned number of cohorts is up to 6 cohorts; additional cohorts may be included if it is considered necessary to repeat a dose level or if additional dose steps are required for safety purposes. Six subjects will receive AZD0186, and two subjects will receive placebo.

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