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The purpose of the study is to compare the pharmacokinetics (PK), safety and tolerability of a single subcutaneous (sc) dose of bimekizumab (BKZ) when administered using bimekizumab-autoinjector (AI)-2mL presentation versus bimekizumab-AI-2x1mL presentation in healthy study participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test | Experimental | Study participants randomized to this arm will receive bimekizumab (BKZ) administered subcutaneously with bimekizumab-AI-2mL presentation (test). |
|
| Reference | Other | Study participants randomized to this arm will receive bimekizumab (BKZ) administered subcutaneously with bimekizumab-AI-1x2mL presentation (reference). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bimekizumab | Drug | Study participants will receive a single dose of bimekizumab (BKZ) administered subcutaneously in the Treatment Period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC) for a Single Dose Bimekizumab (BKZ) | AUC is the area under the plasma concentration-time curve from time 0 (Day 1 predose) to infinity. | Baseline (Day 1 predose) at predefined time points (up to Day 140) |
| Area Under the Plasma Concentration-time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) for a Single Dose Bimekizumab (BKZ) | AUC0-t is the area under the plasma concentration-time curve from time zero (Day 1 predose) to the last quantifiable concentration. | From Baseline (Day 1 predose) at predefined time points to the last quantifiable concentration (Day 140) |
| Maximum Plasma Concentration (Cmax) for a Single Dose Bimekizumab (BKZ) | Cmax is a maximum observed plasma concentration. | From Baseline (Day 1 predose) at predefined time points (up to Day 140) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) From Baseline to End of Safety Follow-Up | An AE is any untoward medical occurrence in a patient or clinical study participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. TEAEs are defined as AEs not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Cares | 001 844 599 2273 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UP0119 2 | Glendale | California | 91206 | United States | ||
| UP0119 1 |
Data from Phase 1 trials in Healthy Volunteers is outside of UCB's data sharing policy and is unavailable for sharing.
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The Participant Flow refers to the Safety Set (SS). The SS consisted of all study participants who randomized and received full or partial investigational medicinal product (IMP) according to the treatment the study participants actually received.
The study started to enroll participants in March 2022 and concluded in January 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Bimekizumab-AI-2mL (Test) | Participants received a single dose of bimekizumab 320 mg (1x320 mg) administered as a subcutaneous injection using a 2 mL auto-injector (AI) on Day 1 of the study. |
| FG001 | Bimekizumab-AI-2x1mL (Reference) | Participants received a single dose of bimekizumab 320 mg (2x160 mg) administered as a subcutaneous injection using 2x1 mL AI on Day 1 of the study. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Baseline characteristics refer to the SS which consisted of all study participants randomized and received full or partial IMP according to the treatment the participants actually received.
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| ID | Title | Description |
|---|---|---|
| BG000 | Bimekizumab-AI-2mL (Test) | Participants received a single dose of bimekizumab 320 mg (1x320 mg) administered as a subcutaneous injection using a 2 mL auto-injector (AI) on Day 1 of the study. |
| BG001 | Bimekizumab-AI-2x1mL (Reference) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC) for a Single Dose Bimekizumab (BKZ) | AUC is the area under the plasma concentration-time curve from time 0 (Day 1 predose) to infinity. | The Pharmacokinetic Set (PKS) was a subset of the SS, consisted of those study participants that received at least 1 total dose of IMP and had at least 1 observable pharmacokinetic measurement and who had no important protocol deviations affecting pharmacokinetics (PK) during the whole study phase. Number of participants analyzed included those participants who were evaluable for the assessment. | Posted | Geometric Least Squares Mean | 95% Confidence Interval | days*micrograms/milliliter (days*ug/mL) | Baseline (Day 1 predose) at predefined time points (up to Day 140) |
|
From Baseline (Day 1) to end of Safety Follow-Up (up to Day 140)
TEAEs are defined as AEs not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. The SS consisted of all study participants who randomized and received full or partial IMP according to the treatment the study participants actually received.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bimekizumab-AI-2mL (Test) | Participants received a single dose of bimekizumab 320 mg (1x320 mg) administered as a subcutaneous injection using a 2 mL auto-injector (AI) on Day 1 of the study. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA (v19.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB | Cares | 001 844 599 2273 | UCBCares@ucb.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 21, 2022 | Mar 21, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 2, 2023 | Mar 21, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000625981 | bimekizumab |
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| From Baseline (Day 1) to end of Safety Follow-Up (up to Day 140) |
| Percentage of Participants With at Least One Treatment-emergent Serious Adverse Event (SAE) From Baseline to End of Safety Follow-Up | A SAE is defined as any untoward medical occurrence that at any dose: a. Results in death, b. Is life-threatening, c. Requires inpatient hospitalization or prolongation of existing hospitalization, d. Results in persistent disability/incapacity, e. Is a congenital anomaly/ birth defect, f. Is an important medical event which based on appropriate medical judgment, jeopardized the study participant and required medical or surgical intervention to prevent any of the above. | From Baseline (Day 1) to end of Safety Follow-Up (up to Day 140) |
| Apparent Terminal Half-life (t1/2) | Apparent terminal half-life as determined via linear regression (slope=-lamdbaz) of the natural log (ln) concentration versus time, for data points in the terminal phase of the concentration time curve (ln2/lambdaz). | From Baseline (Day 1 predose) at predefined time points (up to Day 140) |
| Time of Occurrence of the Maximum Observed Concentration (Tmax) of a Single Dose Bimekizumab (BKZ) | tmax is the time to reach maximum plasma concentration. | From Baseline (Day 1 predose) at predefined time points (up to Day 140) |
| Berlin |
| Germany |
Participants received a single dose of bimekizumab 320 mg (2x160 mg) administered as a subcutaneous injection using 2x1 mL AI on Day 1 of the study.
| BG002 | Total | Total of all reporting groups |
| Years |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| OG001 | Bimekizumab-AI-2x1mL (Reference) | Participants received a single dose of bimekizumab 320 mg (2x160 mg) administered as a subcutaneous injection using 2x1 mL AI on Day 1 of the study. |
|
|
|
| Primary | Area Under the Plasma Concentration-time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) for a Single Dose Bimekizumab (BKZ) | AUC0-t is the area under the plasma concentration-time curve from time zero (Day 1 predose) to the last quantifiable concentration. | The PKS was a subset of the SS, consisted of those study participants that received at least 1 total dose of IMP and had at least 1 observable pharmacokinetic measurement and who had no important protocol deviations affecting PK during the whole study phase. Number of participants analyzed included those participants who were evaluable for the assessment. | Posted | Geometric Least Squares Mean | 95% Confidence Interval | day*ug/mL | From Baseline (Day 1 predose) at predefined time points to the last quantifiable concentration (Day 140) |
|
|
|
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| Primary | Maximum Plasma Concentration (Cmax) for a Single Dose Bimekizumab (BKZ) | Cmax is a maximum observed plasma concentration. | The PKS was a subset of the SS, consisted of those study participants that received at least 1 total dose of IMP and had at least 1 observable pharmacokinetic measurement and who had no important protocol deviations affecting PK during the whole study phase. Number of participants analyzed included those participants who were evaluable for the assessment. | Posted | Geometric Least Squares Mean | 95% Confidence Interval | micrograms/milliliter (ug/mL) | From Baseline (Day 1 predose) at predefined time points (up to Day 140) |
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| Secondary | Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) From Baseline to End of Safety Follow-Up | An AE is any untoward medical occurrence in a patient or clinical study participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. TEAEs are defined as AEs not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. | The SS consisted of all study participants who randomized and received full or partial IMP according to the treatment the study participants actually received. | Posted | Number | percentage of participants | From Baseline (Day 1) to end of Safety Follow-Up (up to Day 140) |
|
|
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| Secondary | Percentage of Participants With at Least One Treatment-emergent Serious Adverse Event (SAE) From Baseline to End of Safety Follow-Up | A SAE is defined as any untoward medical occurrence that at any dose: a. Results in death, b. Is life-threatening, c. Requires inpatient hospitalization or prolongation of existing hospitalization, d. Results in persistent disability/incapacity, e. Is a congenital anomaly/ birth defect, f. Is an important medical event which based on appropriate medical judgment, jeopardized the study participant and required medical or surgical intervention to prevent any of the above. | The SS consisted of all study participants who randomized and received full or partial IMP according to the treatment the study participants actually received. | Posted | Number | percentage of participants | From Baseline (Day 1) to end of Safety Follow-Up (up to Day 140) |
|
|
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| Secondary | Apparent Terminal Half-life (t1/2) | Apparent terminal half-life as determined via linear regression (slope=-lamdbaz) of the natural log (ln) concentration versus time, for data points in the terminal phase of the concentration time curve (ln2/lambdaz). | The PKS was a subset of the SS, consisted of those study participants that received at least 1 total dose of IMP and had at least 1 observable pharmacokinetic measurement and who had no important protocol deviations affecting PK during the whole study phase. Number of participants analyzed included those participants who were evaluable for the assessment. | Posted | Geometric Least Squares Mean | 95% Confidence Interval | days | From Baseline (Day 1 predose) at predefined time points (up to Day 140) |
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| Secondary | Time of Occurrence of the Maximum Observed Concentration (Tmax) of a Single Dose Bimekizumab (BKZ) | tmax is the time to reach maximum plasma concentration. | The PKS was a subset of the SS, consisted of those study participants that received at least 1 total dose of IMP and had at least 1 observable pharmacokinetic measurement and who had no important protocol deviations affecting PK during the whole study phase. Number of participants analyzed included those participants who were evaluable for the assessment. | Posted | Median | Full Range | day | From Baseline (Day 1 predose) at predefined time points (up to Day 140) |
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| 0 |
| 60 |
| 0 |
| 60 |
| 11 |
| 60 |
| EG001 | Bimekizumab-AI-2x1mL (Reference) | Participants received a single dose of bimekizumab 320 mg (2x160 mg) administered as a subcutaneous injection using 2x1 mL AI on Day 1 of the study. | 0 | 61 | 0 | 61 | 16 | 61 |
| Nasopharyngitis | Infections and infestations | MedDRA (v19.0) | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (v19.0) | Non-systematic Assessment |
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