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AZD6912 Dose 1 for Rheumatoid Arthritis

Phase 1

Recruiting

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive and weigh at least 50 kg.

Females must have a negative pregnancy test.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from screening (day -70) to last follow up visit (day 197- approximately 38 weeks)

Awards & highlights

Study Summary

This trial will test the safety and effects of increasing doses of AZD6912 given as a single injection under the skin to healthy volunteers.

Who is the study for?

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.Check my eligibility

What is being tested?

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).See study design

What are the potential side effects?

Possible side effects are not detailed but may include reactions at the injection site or general symptoms like fatigue or headaches as commonly seen with new medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am not pregnant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from screening (day -70) to last follow up visit (day 197- approximately 38 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from screening (day -70) to last follow up visit (day 197- approximately 38 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from screening (day -70) to last follow up visit (day 197- approximately 38 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participants with adverse events (AEs)

Secondary outcome measures

Apparent total body clearance of drug from plasma after extravascular administration (CL/F) of AZD6912

Area under plasma concentration-time curve from zero to infinity (AUCinf) of AZD6912

Area under the plasma concentration-curve from zero to the last quantifiable concentration (AUClast) of AZD6912

+11 more

Trial Design

9Treatment groups

Experimental Treatment

Placebo Group

Group I: AZD6912 additional cohort 2 -including Japanese ParticipantsExperimental Treatment1 Intervention

Participants will receive AZD6912.

Group II: AZD6912 additional cohort 1 -including Japanese ParticipantsExperimental Treatment1 Intervention

Participants will receive AZD6912.

Group III: AZD6912 Dose 6Experimental Treatment1 Intervention

Participants will receive AZD6912 Dose 6.

Group IV: AZD6912 Dose 5Experimental Treatment1 Intervention

Participants will receive AZD6912 Dose 5.

Group V: AZD6912 Dose 4Experimental Treatment1 Intervention

Participants will receive AZD6912 Dose 4.

Group VI: AZD6912 Dose 3Experimental Treatment1 Intervention

Participants will receive AZD6912 Dose 3.

Group VII: AZD6912 Dose 2Experimental Treatment1 Intervention

Participants will receive AZD6912 Dose 2.

Group VIII: AZD6912 Dose 1Experimental Treatment1 Intervention

Participants will receive AZD6912 Dose 1.

Group IX: PlaceboPlacebo Group1 Intervention

Participants will receive Placebo.

0 / 2Eligibility criteria met

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

AstraZenecaLead Sponsor

4,271 Previous Clinical Trials

288,612,639 Total Patients Enrolled

32 Trials studying Rheumatoid Arthritis

16,621 Patients Enrolled for Rheumatoid Arthritis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this medical study have an age criterion that allows participation for individuals beyond the age of 55?

"Eligible candidates for this research study must be between the ages of 18 and 50. It is worth noting that there are a total of 53 studies available specifically for individuals below the age of consent, and an additional 312 studies targeting patients over the age of 65."

Answered by AI

What is the current number of individuals being recruited for participation in this clinical investigation?

"Indeed, the data available on clinicaltrials.gov indicates that this ongoing clinical trial is actively seeking eligible participants. The initial posting of the trial occurred on November 15th, 2023, and the most recent update was made on January 12th, 2024. A total of 64 individuals will be enrolled in this study across two designated sites."

Answered by AI

Are potential participants still able to apply for enrollment in this ongoing research study?

"Indeed, as stated on clinicaltrials.gov, this research investigation is currently actively seeking eligible participants. The trial was initially posted for public awareness on November 15th, 2023 and subsequently updated most recently on January 12th, 2024."

Answered by AI

What level of risk does AZD6912 Dose 1 pose to patients?

"Our team at Power rates the safety of AZD6912 Dose 1 as a 1 on a scale from 1 to 3. This is because it is a Phase 1 trial, where there is limited data available supporting both safety and efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of Subcutaneous AZD6912 in Healthy Participants

2023. "A Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of Subcutaneous AZD6912 in Healthy Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06115967.

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