Safety Study of AZD6912 in Healthy Volunteers

Recruiting at 2 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: AstraZeneca

Disqualifiers: Cardiac abnormalities, Hepatitis, HIV, others

Compensation: Varies

Number of Visits: 16

Duration: 11 days

64 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single ascending doses of AZD6912 administered subcutaneously (SC) in healthy participants.

Will I have to stop taking my current medications?

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.

Eligibility Criteria

This trial is for healthy individuals of Japanese descent, with a BMI between 18 and 30 kg/m2 and weighing at least 50 kg. Participants must be born to two Japanese parents and four Japanese grandparents, have lived in Japan, not abroad for over five years, maintain a consistent lifestyle since leaving Japan, and use contraception.

Inclusion Criteria

Use of contraceptives by both genders must comply with local rules.

My BMI is between 18 and 30, and I weigh at least 50 kg.

You are a first-generation Japanese citizen, with both of your parents and all four grandparents born in Japan.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

10 weeks

Treatment

Participants receive a single ascending dose of AZD6912 or placebo and are monitored in the Clinical Unit

11 days

Inpatient stay from Day -1 to Day 11

Follow-up

Participants are monitored for safety, tolerability, pharmacokinetics, and pharmacodynamics after treatment

27 weeks

Weekly visits from Day 15, bi-weekly from Day 43, 4-weekly from Day 99, 6-weekly from Day 155

Treatment Details

Interventions

• AZD6912
• Placebo

Trial Overview The study tests AZD6912 given under the skin against a placebo in healthy people to check its safety, how well it's tolerated, how the body processes it (PK), and how it affects the body (PD).

Participant Groups

Group I: AZD6912 additional Japanese cohort 2 Experimental Treatment 1 Intervention

Participants will receive AZD6912.

Group II: AZD6912 additional Japanese cohort 1 Experimental Treatment 1 Intervention

Participants will receive AZD6912.

Group III: AZD6912 Dose 6 Experimental Treatment 1 Intervention

Participants will receive AZD6912 Dose 6.

Group IV: AZD6912 Dose 5 Experimental Treatment 1 Intervention

Participants will receive AZD6912 Dose 5.

Group V: AZD6912 Dose 4 Experimental Treatment 1 Intervention

Participants will receive AZD6912 Dose 4.

Group VI: AZD6912 Dose 3 Experimental Treatment 1 Intervention

Participants will receive AZD6912 Dose 3.

Group VII: AZD6912 Dose 2 Experimental Treatment 1 Intervention

Participants will receive AZD6912 Dose 2.

Group VIII: AZD6912 Dose 1 Experimental Treatment 1 Intervention

Participants will receive AZD6912 Dose 1.

Group IX: Placebo Placebo Group 1 Intervention

Participants 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