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Monoclonal Antibodies

bimekizumab for Healthy Volunteers

Phase 1
Waitlist Available
Research Sponsored by UCB Biopharma SRL
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Study participant must be ≥18 years and ≤65 years of age inclusive, at the time of signing the informed consent
Study participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and laboratory tests, during the Screening Period and on admission
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline (day 1) to end of safety follow-up (up to day 140)
Awards & highlights

Study Summary

This trial is testing a new way to give a medication, to see if it is safer and more tolerable than the current method.

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline (day 1) to end of safety follow-up (up to day 140)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (day 1) to end of safety follow-up (up to day 140) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area under the plasma concentration-time curve from time zero to infinity (AUC) for a single dose bimekizumab (BKZ)
Area under the plasma concentration-time curve from time zero to last quantifiable concentration (AUC0-t) for a single dose bimekizumab (BKZ)
Maximum plasma concentration (Cmax) for a single dose bimekizumab (BKZ)
Secondary outcome measures
Apparent terminal half-life (t1/2)
Percentage of participants with at least one treatment-emergent adverse event (TEAE) from Baseline to end of Safety Follow-Up
Percentage of participants with at least one treatment-emergent serious adverse event (SAE) from Baseline to end of Safety Follow-Up
+1 more

Side effects data

From 2022 Phase 3 trial • 47 Patients • NCT05020249
22%
Corona virus infection
6%
Tinea pedis
6%
Eczema
3%
Bacteriuria
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bimekizumab 320 mg Q4W
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Group I: TestExperimental Treatment1 Intervention
Study participants randomized to this arm will receive bimekizumab (BKZ) administered subcutaneously with bimekizumab-AI-2mL presentation (test).
Group II: ReferenceExperimental Treatment1 Intervention
Study participants randomized to this arm will receive bimekizumab (BKZ) administered subcutaneously with bimekizumab-AI-1x2mL presentation (reference).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
bimekizumab
2021
Completed Phase 3
~170

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

UCB Biopharma SRLLead Sponsor
101 Previous Clinical Trials
21,302 Total Patients Enrolled
UCB CaresStudy Director001 844 599 2273
205 Previous Clinical Trials
44,829 Total Patients Enrolled

Frequently Asked Questions

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

Is there currently an opportunity for sufferers to partake in this trial?

"Per the information on clinicaltrials.gov, this research is not presently seeking volunteers. This initiative was first posted on March 17th 2022 and most recently updated in September of that same year. Nevertheless, there are two other trials currently accepting participants."

Answered by AI

Would I be an eligible participant in this experiment?

"This clinical trial is targeting 121 individuals aged 18-65 who present with no underlying medical issues. Additionally, they must have a body temperature between 35 and 37.5 degrees Celsius at screening and admission, weigh between 45 to 100 kilograms (depending on gender), maintain a BMI of 18-32 kg/m^2, follow UCB contraceptive guidelines where applicable, and be either male or female."

Answered by AI

What adverse effects may be exhibited by those utilizing bimekizumab?

"As this is a Phase 1 trial, and thus has limited evidence to support its efficacy and safety profile, our team at Power estimated the risk of bimekizumab use with a score of one."

Answered by AI

What is the principal aim of this experiment?

"According to the study sponsor, UCB Biopharma SRL, this trial is gauging Maximum plasma concentration (Cmax) of a single dose bimekizumab (BKZ). Additional metrics that will be evaluated include Percentage of participants with at least one treatment-emergent serious adverse event (SAE), Time of occurrence of the maximum observed concentration (tmax) and Apparent terminal half-life (t1/2)."

Answered by AI

Does this experiment admit individuals over the age of 30?

"The enrollment parameters for this clinical trial are clear - the minimum age requirement is 18 and no participant can exceed 65 years of age."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Bioequivalence Study of Bimekizumab Given as 1x2mL or 2x1mL Subcutaneous Injection Using an Autoinjector in Healthy Study Participants
2022. "A Bioequivalence Study of Bimekizumab Given as 1x2mL or 2x1mL Subcutaneous Injection Using an Autoinjector in Healthy Study Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05292131.
~40 spots leftby Apr 2025
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