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Safety Study of AZD6912 in Healthy Volunteers
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)
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.
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).
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 belowSelect...
My BMI is between 18 and 30, and I weigh at least 50 kg.
Select...
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)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of participants with adverse events (AEs)
Secondary study objectives
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
+10 moreTrial Design
9Treatment groups
Experimental Treatment
Placebo Group
Group I: AZD6912 additional Japanese cohort 2Experimental Treatment1 Intervention
Participants will receive AZD6912.
Group II: AZD6912 additional Japanese cohort 1Experimental 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.
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
AstraZenecaLead Sponsor
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