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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to day 71

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to day 71

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

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

Primary outcome measures

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

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 A

2023

Completed Phase 1

~50

Lutikizumab Dose B

2023

Completed Phase 1

~50

0 / 1Eligibility criteria met

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

AbbVieLead Sponsor

954 Previous Clinical Trials

501,055 Total Patients Enrolled

ABBVIE INC.Study DirectorAbbVie

394 Previous Clinical Trials

145,889 Total Patients Enrolled

Frequently Asked Questions

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

Are elderly individuals being considered for enrollment in this research endeavor?

"Eligible participants must be at least 18 but not more than 60 years old."

Answered by AI

Is the first dosage of Part 1 medically safe for patients?

"The safety of Dose A in Part 1 is estimated to be a score of one, as this phase 1 trial has only limited data demonstrating its efficacy and security."

Answered by AI

Are there any open opportunities to participate in this research study?

"Clinicaltrials.gov indicates that this research project, which was announced on September 28th 2023, is actively seeking volunteers. The listing was most recently updated a week later on October 4th."

Answered by AI

How many people are registering for this research endeavour?

"Correct. Clinicaltrials.gov presents the evidence that this research project, which was initially published on September 28th 2023, is currently searching for candidates. The study needs to recruit 50 individuals from a single medical centre."

Answered by AI

Is there a specific demographic of individuals who are eligible to participate in this research trial?

"This clinical trial is recruiting 50 qualified subjects between 18 and 60 years old. To be eligible, one must possess the following prerequisites: gender congruent with their birth assignment, Han Chinese ancestry from two full-blooded parents not living in China, a BMI of no greater than 29.9 kg/m^2 at screening and confinement commencement, as well as general health attested to by medical history reports, physical examinations, vital signs evaluations, laboratory results assessments and ECG readings."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Relative Bioavailability of Two Lutikizumab Formulations and Pharmacokinetics, Safety, and Tolerability of Lutikizumab in Chinese Participants

2023. "Relative Bioavailability of Two Lutikizumab Formulations and Pharmacokinetics, Safety, and Tolerability of Lutikizumab in Chinese Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06067568.

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