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Monoclonal Antibodies

Lutikizumab Bioavailability in Healthy Subjects

Phase 1
Waitlist Available
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male and female healthy volunteers aged between 18 and 60 years
Be between 18 and 65 years old
Must not have
History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma), renal, hepatic, gastrointestinal, hematologic, demyelinating disease (including myelitis) or neurologic symptoms suggestive of demyelinating disease, glaucoma, psychiatric disease or disorder, or any uncontrolled medical illness
Prior exposure to lutikizumab.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to day 71
Awards & highlights
No Placebo-Only Group

Summary

This trial compares how a medication is absorbed and affects the body in healthy Chinese people. It also checks for side effects.

Who is the study for?
Healthy Chinese volunteers, aged 18-60, who are first-generation Han Chinese living outside China and maintaining a typical Chinese lifestyle. They must have a BMI between 18.0 to 29.9 and be in good health based on medical exams. Participants cannot have used medications or supplements recently, nor can they have had prior exposure to lutikizumab or significant medical conditions.
What is being tested?
The study is testing two different formulations of lutikizumab (Dose A and Dose B) in healthy participants to see how the body absorbs each one and what effects they might have. The trial will monitor any adverse events as well as track the movement of the drug through the body.
What are the potential side effects?
While specific side effects for lutikizumab aren't listed, common ones may include reactions at the injection site, headaches, nausea, fatigue or allergic responses. Safety assessments like physical exams and lab tests will help identify any other potential side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 60 years old and in good health.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have any significant ongoing health issues like epilepsy, heart problems, or severe asthma.
Select...
I have previously been treated with lutikizumab.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to day 71
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to day 71 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
AUC from Time 0 to Infinity (AUC0-inf) of Lutikizumab
Apparent Terminal Phase Elimination Rate Constant (β) of Lutikizumab
Area under the Serum Concentration-time Curve (AUC) from Time 0 to the Time of the Last Measurable Concentration (AUC0-t) of Lutikizumab
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Part 2Experimental Treatment1 Intervention
Han Chinese participants will receive a single dose of Lutikizumab.
Group II: Part 1, Dose BExperimental Treatment1 Intervention
Participants will receive a single dose of Lutikizumab Dose B.
Group III: Part 1, Dose AExperimental Treatment1 Intervention
Participants will receive a single dose of Lutikizumab Dose A.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lutikizumab Dose B
2023
Completed Phase 1
~50
Lutikizumab Dose A
2023
Completed Phase 1
~50

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

AbbVieLead Sponsor
1,020 Previous Clinical Trials
520,078 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
442 Previous Clinical Trials
160,527 Total Patients Enrolled
~24 spots leftby Nov 2025
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