Healthy Study Participants
Conditions
Keywords
Healthy Study Participants, Phase 1, rozanolixizumab, manual push, syringe driver
Brief summary
The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of a single subcutaneous (SC) dose of rozanolixizumab administered to healthy participants by manual push (MP) versus (vs) syringe driver.
Interventions
DRUGrozanolixizumab
Study participants will receive a single dose rozanolixizumab subcutaneously administered by manual push or a syringe driver.
OTHERPlacebo
Study participants will receive a single dose placebo subcutaneously administered by manual push or a syringe driver.
Sponsors
UCB Biopharma SRL
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Masking description
This is a participant-blind and investigator-blind study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Study participant must be 18 to 65 years of age, inclusive * Study participants who are overtly healthy in the opinion of the investigator as determined by medical evaluation including medical history, a general clinical examination, including physical examination and laboratory tests, and cardiac monitoring * Study participant has blood pressure (BP) and pulse within normal range in a supine position after 5 minutes of rest (systolic BP: 90 to 140 mmHg, diastolic BP: 50 to 90 mmHg, pulse: 40 to 90 beats per minute (bpm)) * Study participant has clinical laboratory test results within the reference ranges of the testing laboratory or not clinically significant if outside the specified ranges, in the opinion of the investigator * Study participant's electrocardiogram (ECG) is considered normal or abnormal but clinically nonsignificant (as interpreted by the investigator) * Study participants may be male or female * Participant has a body mass index of 18 to 32 kg/m\^2, with a minimum body weight of 35 kg
Exclusion criteria
* History or presence of/significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders. Has active neoplastic disease or history of neoplastic disease within the previous 5 years of entry in the clinical study (except for basal or squamous cell carcinoma of the skin or carcinoma in situ that has been definitively treated with standard of care approaches). Has a history of a major organ transplant or hematopoietic stem cell/marrow transplant * Symptomatic herpes zoster within 3 months prior to Screening * Allergies to humanized monoclonal antibodies * Female who is pregnant or lactating * Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe posttreatment hypersensitivity reactions * Evidence of active or latent tuberculosis (TB) as documented by medical history and examination * Predicted inability to comply with being free of caffeine and ethanol from 72 hours prior to clinic admission and during the In-Clinic Period of the study * Known hypersensitivity to oral paracetamol (acetaminophen) * History of known inflammatory bowel disease, active diverticular disease, or a history of confirmed duodenal, gastric, or esophageal ulceration in the previous 6 months * History of hyperprolinemia, since L-proline is a constituent of rozanolixizumab. * Twelve-lead ECG with abnormalities considered to be clinically significant upon medical review * Renal impairment, defined as a creatinine concentration in serum of ≥1.4 mg/dL (≥123 μmol/L) for female participants and ≥1.5 mg/dL (≥132 μmol/L) for male participants * Known viral hepatitis (B and C) or human immunodeficiency virus 1/2 antibodies or has a past medical history or family history of primary immunodeficiency or antibodies to human immunodeficiency virus type 1 and/or type 2 at Screening * Participant has a positive test result for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in reverse transcriptase-polymerase chain reaction on admission to the unit * Participant has clinical signs and symptoms consistent with SARS-CoV-2 (eg, fever, dry cough, dyspnea, sore throat, fatigue) or confirmed infection by appropriate laboratory test within the previous 14 days prior to Screening or on admission * Participant has active infection or is symptomatic with SARS-CoV-2 or is currently in quarantine (has been in contact with a SARS-CoV-2 positive individual in the last 14 days) * Participant has had a severe course of SARS-CoV-2 (eg, requiring extracorporeal membrane oxygenation, mechanical ventilation, or hospitalization) * Past or intended use of over-the-counter or prescription medication (including herbal medications) within 14 days prior to dosing until Day 57 * Live vaccine(s) within 8 weeks prior to Screening or plans to receive such vaccines during the study or is within a dosing cycle to receive a second dose of a coronavirus disease-19 (COVID-19) vaccine, or within 2 weeks of having received a COVID-19 vaccine * Treatment with biologic agents (such as monoclonal antibodies including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing * Exposure to more than 3 new chemical entities within 12 months prior to dosing * Has previously been assigned to treatment in a clinical study of rozanolixizumab * Participated in another study of an investigational medicinal product (IMP) (or a medical device) within the previous 90 days or 5 half-lives prior to Day -1 (whichever is longer) or is currently participating in another study of an IMP (or a medical device) * Immunoglobulin G \<7g/L or \>16g/L at the Screening Visit * Participant is splenectomized or has had an active clinically significant infection within the last 6 weeks * Donated or lost \>500 mL of blood or blood products in the 3 months preceding the start of dosing or plans to donate blood during the clinical study * Employee or direct relative of an employee of the contract research organization (CRO) or UCB * History of alcohol and/or drug abuse up to 12 months before Screening * Smoked on average \>5 cigarettes/day (or equivalent) during the last 3 months and is not able to stop smoking during the In-Clinic Period * Excessive consumption of beverages or food containing xanthine bases (including caffeinated drinks, coffee, chocolate, etc.), equating to \>400 mg caffeine per day
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57) | A TEAE was defined as any adverse event (AE) with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Plasma Concentration (Cmax) of a Single Dose Rozanolixizumab | Sampling time points for plasma Pharmacokinetics were as follows: predose, immediately at the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours after start of infusion, and on Days 7, 10, 13, and 16 | Cmax was the maximum plasma concentration of a single dose rozanolixizumab. Cmax was measured in micrograms per millilitre per milligram (ug/mL/mg). |
| Time to Maximum Plasma Concentration (Tmax) of a Single Dose Rozanolixizumab | Sampling time points for plasma Pharmacokinetics were as follows: predose, immediately at the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours after start of infusion, and on Days 7, 10, 13, and 16 | tmax was the time to maximum plasma concentration of a single dose rozanolixizumab. |
| Area Under the Plasma Concentration-time Curve From Time Zero to Time t (AUC0-t) of a Single Dose Rozanolixizumab | Sampling time points for plasma Pharmacokinetics were as follows: predose, immediately at the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours after start of infusion, and on Days 7, 10, 13, and 16 | AUC0-t was the area under the plasma concentration-time curve from time zero to time t of a single dose rozanolixizumab. |
| Baseline-corrected Area Under the Total Immunglobulin (Ig) G-time Curve | Sampling time points for total IgG were as follows: 24, 36, 48, 72, and 96 hours after start of infusion, and on Days 7, 10, 13, 16, 19, 22, 29, 43 and 57 | Area under the baseline-corrected total IgG response curve from time 0 to time t. |
| Percent Maximum Decrease in Total Plasma IgG (Rmin) of a Single Dose Rozanolixizumab or Placebo | Sampling time points for total IgG were as follows: 24, 36, 48, 72, and 96 hours after start of infusion, and on Days 7, 10, 13, 16, 19, 22, 29, 43 and 57 | Rmin was the maximum (max) decrease in total plasma IgG of a single dose rozanolixizumab or placebo. |
| Time to Minimum IgG Level (Tmin) of a Single Dose Rozanolixizumab or Placebo | Sampling time points for total IgG were as follows: 24, 36, 48, 72, and 96 hours after start of infusion, and on Days 7, 10, 13, 16, 19, 22, 29, 43 and 57 | tmin was the time to minimum IgG level of a single dose rozanolixizumab or placebo. |
Countries
United Kingdom
Participant flow
Recruitment details
The study started to enroll participants in April 2021 and concluded in April 2022.
Pre-assignment details
The Participant Flow refers to the Randomized Set.
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1: Syringe Driver- RLZ Dose 1 (>=35 kg to <50 kg) Participants with body weight greater than or equal to (\>=) 35 Kilograms (kg) to less than (\<) 50 kg received a single dose of rozanolixizumab (RLZ) Dose 1, subcutaneously, with a syringe driver on Day 1 of the study. | 6 |
| Cohort 1: Syringe Driver- PBO (>=35 kg to <50 kg) Participants with body weight \>=35 kg to \<50 kg received a single dose of placebo (PBO), subcutaneously, with a syringe driver on Day 1 of the study. | 2 |
| Cohort 2: Manual Push- RLZ Dose 2 (>=35 kg to <50 kg) Participants with body weight \>=35 kg to \<50 kg received a single dose of RLZ Dose 2, subcutaneously, administered by manual push (MP) on Day 1 of the study. | 6 |
| Cohort 2: Manual Push- PBO (>=35 kg to <50 kg) Participants with body weight \>=35 kg to \<50 kg received a single dose of PBO, subcutaneously, administered by MP on Day 1 of the study. | 2 |
| Cohort 3: Syringe Driver- RLZ Dose 1 (>=50 kg) Participants with body weight \>=50 kg received a single dose of RLZ Dose 1, subcutaneously, with a syringe driver on Day 1 of the study. | 6 |
| Cohort 3: Syringe Driver- PBO (>=50 kg) Participants with body weight \>=50 kg received a single dose of PBO, subcutaneously, with a syringe driver on Day 1 of the study. | 2 |
| Cohort 4: Manual Push- RLZ Dose 1 (>=50 kg) Participants with body weight \>=50 kg received a single dose of RLZ Dose 1, subcutaneously, administered by MP on Day 1 of the study. | 6 |
| Cohort 4: Manual Push- PBO (>=50 kg) Participants with body weight \>=50 kg received a single dose of PBO, subcutaneously, administered by MP on Day 1 of the study. | 2 |
| Total | 32 |
Baseline characteristics
| Characteristic | Total | Cohort 1: Syringe Driver- PBO (>=35 kg to <50 kg) | Cohort 1: Syringe Driver- RLZ Dose 1 (>=35 kg to <50 kg) | Cohort 2: Manual Push- RLZ Dose 2 (>=35 kg to <50 kg) | Cohort 2: Manual Push- PBO (>=35 kg to <50 kg) | Cohort 3: Syringe Driver- RLZ Dose 1 (>=50 kg) | Cohort 3: Syringe Driver- PBO (>=50 kg) | Cohort 4: Manual Push- RLZ Dose 1 (>=50 kg) | Cohort 4: Manual Push- PBO (>=50 kg) |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 32 Participants | 2 Participants | 6 Participants | 6 Participants | 2 Participants | 6 Participants | 2 Participants | 6 Participants | 2 Participants |
| Age, Continuous | 37.4 years STANDARD_DEVIATION 12.1 | NA years | 36.7 years STANDARD_DEVIATION 15.7 | 33.2 years STANDARD_DEVIATION 9.5 | NA years | 39.3 years STANDARD_DEVIATION 8.1 | NA years | 45.5 years STANDARD_DEVIATION 12.7 | NA years |
| Race/Ethnicity, Customized Asian | 13 Participants | 1 Participants | 4 Participants | 6 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 4 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 28 Participants | 2 Participants | 5 Participants | 6 Participants | 2 Participants | 4 Participants | 2 Participants | 5 Participants | 2 Participants |
| Race/Ethnicity, Customized Other or Mixed | 3 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 15 Participants | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 4 Participants | 2 Participants | 4 Participants | 2 Participants |
| Sex: Female, Male Female | 21 Participants | 2 Participants | 6 Participants | 6 Participants | 2 Participants | 2 Participants | 0 Participants | 2 Participants | 1 Participants |
| Sex: Female, Male Male | 11 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 4 Participants | 2 Participants | 4 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 2 | 0 / 6 | 0 / 2 | 0 / 6 | 0 / 2 | 0 / 6 | 0 / 2 |
| other Total, other adverse events | 5 / 6 | 1 / 2 | 6 / 6 | 1 / 2 | 5 / 6 | 0 / 2 | 5 / 6 | 2 / 2 |
| serious Total, serious adverse events | 0 / 6 | 0 / 2 | 0 / 6 | 0 / 2 | 0 / 6 | 0 / 2 | 0 / 6 | 0 / 2 |
Outcome results
Primary
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
A TEAE was defined as any adverse event (AE) with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication.
Time frame: From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
Population: The Safety Analysis Set (SS) included all randomized study participants who received IMP.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: Syringe Driver- RLZ Dose 1 (>=35 kg to <50 kg) | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | 83.3 percentage of participants |
| Cohort 1: Syringe Driver- PBO (>=35 kg to <50 kg) | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | 50.0 percentage of participants |
| Cohort 2: Manual Push- RLZ Dose 2 (>=35 kg to <50 kg) | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | 100 percentage of participants |
| Cohort 2: Manual Push- PBO (>=35 kg to <50 kg) | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | 50.0 percentage of participants |
| Cohort 3: Syringe Driver- RLZ Dose 1 (>=50 kg) | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | 83.3 percentage of participants |
| Cohort 3: Syringe Driver- PBO (>=50 kg) | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | 0 percentage of participants |
| Cohort 4: Manual Push- RLZ Dose 1 (>=50 kg) | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | 83.3 percentage of participants |
| Cohort 4: Manual Push- PBO (>=50 kg) | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | 100 percentage of participants |
Secondary
Area Under the Plasma Concentration-time Curve From Time Zero to Time t (AUC0-t) of a Single Dose Rozanolixizumab
AUC0-t was the area under the plasma concentration-time curve from time zero to time t of a single dose rozanolixizumab.
Time frame: Sampling time points for plasma Pharmacokinetics were as follows: predose, immediately at the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours after start of infusion, and on Days 7, 10, 13, and 16
Population: The Pharmacokinetic Per Protocol Set (PK-PPS) included all study participants who received active study medication and had at least 1 observable PK measurement and had no IPDs affecting the PK parameters. Here, number of participants analyzed included those participants who were evaluable for the outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Syringe Driver- RLZ Dose 1 (>=35 kg to <50 kg) | Area Under the Plasma Concentration-time Curve From Time Zero to Time t (AUC0-t) of a Single Dose Rozanolixizumab | 2.408 hours*ug/mL/mg | Geometric Coefficient of Variation 55.4 |
| Cohort 1: Syringe Driver- PBO (>=35 kg to <50 kg) | Area Under the Plasma Concentration-time Curve From Time Zero to Time t (AUC0-t) of a Single Dose Rozanolixizumab | 0.1436 hours*ug/mL/mg | Geometric Coefficient of Variation 266.7 |
| Cohort 2: Manual Push- RLZ Dose 2 (>=35 kg to <50 kg) | Area Under the Plasma Concentration-time Curve From Time Zero to Time t (AUC0-t) of a Single Dose Rozanolixizumab | 0.4223 hours*ug/mL/mg | Geometric Coefficient of Variation 687 |
| Cohort 2: Manual Push- PBO (>=35 kg to <50 kg) | Area Under the Plasma Concentration-time Curve From Time Zero to Time t (AUC0-t) of a Single Dose Rozanolixizumab | 2.111 hours*ug/mL/mg | Geometric Coefficient of Variation 80.5 |
Secondary
Baseline-corrected Area Under the Total Immunglobulin (Ig) G-time Curve
Area under the baseline-corrected total IgG response curve from time 0 to time t.
Time frame: Sampling time points for total IgG were as follows: 24, 36, 48, 72, and 96 hours after start of infusion, and on Days 7, 10, 13, 16, 19, 22, 29, 43 and 57
Population: Pharmacodynamic Per Protocol Set (PD-PPS) was a subset of the Safety Set (SS) which included study participants who had no IPDs affecting the PD variables, as confirmed during a pre-analysis review of the data prior to database lock. Here, number of participants analyzed included those participants who were evaluable for the outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Syringe Driver- RLZ Dose 1 (>=35 kg to <50 kg) | Baseline-corrected Area Under the Total Immunglobulin (Ig) G-time Curve | -190.6 grams*day/Litre (g*day/L) | Standard Deviation 66.1 |
| Cohort 1: Syringe Driver- PBO (>=35 kg to <50 kg) | Baseline-corrected Area Under the Total Immunglobulin (Ig) G-time Curve | NA grams*day/Litre (g*day/L) | — |
| Cohort 2: Manual Push- RLZ Dose 2 (>=35 kg to <50 kg) | Baseline-corrected Area Under the Total Immunglobulin (Ig) G-time Curve | -101.0 grams*day/Litre (g*day/L) | Standard Deviation 118.4 |
| Cohort 2: Manual Push- PBO (>=35 kg to <50 kg) | Baseline-corrected Area Under the Total Immunglobulin (Ig) G-time Curve | NA grams*day/Litre (g*day/L) | — |
| Cohort 3: Syringe Driver- RLZ Dose 1 (>=50 kg) | Baseline-corrected Area Under the Total Immunglobulin (Ig) G-time Curve | -141.8 grams*day/Litre (g*day/L) | Standard Deviation 52.99 |
| Cohort 3: Syringe Driver- PBO (>=50 kg) | Baseline-corrected Area Under the Total Immunglobulin (Ig) G-time Curve | NA grams*day/Litre (g*day/L) | — |
| Cohort 4: Manual Push- RLZ Dose 1 (>=50 kg) | Baseline-corrected Area Under the Total Immunglobulin (Ig) G-time Curve | -168.8 grams*day/Litre (g*day/L) | Standard Deviation 49.7 |
| Cohort 4: Manual Push- PBO (>=50 kg) | Baseline-corrected Area Under the Total Immunglobulin (Ig) G-time Curve | NA grams*day/Litre (g*day/L) | — |
Secondary
Maximum Plasma Concentration (Cmax) of a Single Dose Rozanolixizumab
Cmax was the maximum plasma concentration of a single dose rozanolixizumab. Cmax was measured in micrograms per millilitre per milligram (ug/mL/mg).
Time frame: Sampling time points for plasma Pharmacokinetics were as follows: predose, immediately at the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours after start of infusion, and on Days 7, 10, 13, and 16
Population: The Pharmacokinetic Per Protocol Set (PK-PPS) included all study participants who received active study medication and had at least 1 observable PK measurement and had no important protocol deviation (IPDs) affecting the PK parameters. Here, number of participants analyzed included those participants who were evaluable for the outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Syringe Driver- RLZ Dose 1 (>=35 kg to <50 kg) | Maximum Plasma Concentration (Cmax) of a Single Dose Rozanolixizumab | 0.03352 ug/mL/mg | Geometric Coefficient of Variation 52.8 |
| Cohort 1: Syringe Driver- PBO (>=35 kg to <50 kg) | Maximum Plasma Concentration (Cmax) of a Single Dose Rozanolixizumab | 0.004066 ug/mL/mg | Geometric Coefficient of Variation 127 |
| Cohort 2: Manual Push- RLZ Dose 2 (>=35 kg to <50 kg) | Maximum Plasma Concentration (Cmax) of a Single Dose Rozanolixizumab | 0.007293 ug/mL/mg | Geometric Coefficient of Variation 644.1 |
| Cohort 2: Manual Push- PBO (>=35 kg to <50 kg) | Maximum Plasma Concentration (Cmax) of a Single Dose Rozanolixizumab | 0.02752 ug/mL/mg | Geometric Coefficient of Variation 82.2 |
Secondary
Percent Maximum Decrease in Total Plasma IgG (Rmin) of a Single Dose Rozanolixizumab or Placebo
Rmin was the maximum (max) decrease in total plasma IgG of a single dose rozanolixizumab or placebo.
Time frame: Sampling time points for total IgG were as follows: 24, 36, 48, 72, and 96 hours after start of infusion, and on Days 7, 10, 13, 16, 19, 22, 29, 43 and 57
Population: Pharmacodynamic Per Protocol Set (PD-PPS) was a subset of the Safety Set (SS) which included study participants who had no IPDs affecting the PD variables, as confirmed during a pre-analysis review of the data prior to database lock.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Syringe Driver- RLZ Dose 1 (>=35 kg to <50 kg) | Percent Maximum Decrease in Total Plasma IgG (Rmin) of a Single Dose Rozanolixizumab or Placebo | -46.73 percent max decrease in total plasma IgG | Standard Deviation 14.76 |
| Cohort 1: Syringe Driver- PBO (>=35 kg to <50 kg) | Percent Maximum Decrease in Total Plasma IgG (Rmin) of a Single Dose Rozanolixizumab or Placebo | NA percent max decrease in total plasma IgG | — |
| Cohort 2: Manual Push- RLZ Dose 2 (>=35 kg to <50 kg) | Percent Maximum Decrease in Total Plasma IgG (Rmin) of a Single Dose Rozanolixizumab or Placebo | -42.14 percent max decrease in total plasma IgG | Standard Deviation 13.31 |
| Cohort 2: Manual Push- PBO (>=35 kg to <50 kg) | Percent Maximum Decrease in Total Plasma IgG (Rmin) of a Single Dose Rozanolixizumab or Placebo | NA percent max decrease in total plasma IgG | — |
| Cohort 3: Syringe Driver- RLZ Dose 1 (>=50 kg) | Percent Maximum Decrease in Total Plasma IgG (Rmin) of a Single Dose Rozanolixizumab or Placebo | -44.03 percent max decrease in total plasma IgG | Standard Deviation 8.711 |
| Cohort 3: Syringe Driver- PBO (>=50 kg) | Percent Maximum Decrease in Total Plasma IgG (Rmin) of a Single Dose Rozanolixizumab or Placebo | NA percent max decrease in total plasma IgG | — |
| Cohort 4: Manual Push- RLZ Dose 1 (>=50 kg) | Percent Maximum Decrease in Total Plasma IgG (Rmin) of a Single Dose Rozanolixizumab or Placebo | -42.90 percent max decrease in total plasma IgG | Standard Deviation 10.67 |
| Cohort 4: Manual Push- PBO (>=50 kg) | Percent Maximum Decrease in Total Plasma IgG (Rmin) of a Single Dose Rozanolixizumab or Placebo | NA percent max decrease in total plasma IgG | — |
Secondary
Time to Maximum Plasma Concentration (Tmax) of a Single Dose Rozanolixizumab
tmax was the time to maximum plasma concentration of a single dose rozanolixizumab.
Time frame: Sampling time points for plasma Pharmacokinetics were as follows: predose, immediately at the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours after start of infusion, and on Days 7, 10, 13, and 16
Population: The Pharmacokinetic Per Protocol Set (PK-PPS) included all study participants who received active study medication and had at least 1 observable PK measurement and had no IPDs affecting the PK parameters. Here, number of participants analyzed included those participants who were evaluable for the outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1: Syringe Driver- RLZ Dose 1 (>=35 kg to <50 kg) | Time to Maximum Plasma Concentration (Tmax) of a Single Dose Rozanolixizumab | 60.10 hours |
| Cohort 1: Syringe Driver- PBO (>=35 kg to <50 kg) | Time to Maximum Plasma Concentration (Tmax) of a Single Dose Rozanolixizumab | 48.03 hours |
| Cohort 2: Manual Push- RLZ Dose 2 (>=35 kg to <50 kg) | Time to Maximum Plasma Concentration (Tmax) of a Single Dose Rozanolixizumab | 72.00 hours |
| Cohort 2: Manual Push- PBO (>=35 kg to <50 kg) | Time to Maximum Plasma Concentration (Tmax) of a Single Dose Rozanolixizumab | 72.00 hours |
Secondary
Time to Minimum IgG Level (Tmin) of a Single Dose Rozanolixizumab or Placebo
tmin was the time to minimum IgG level of a single dose rozanolixizumab or placebo.
Time frame: Sampling time points for total IgG were as follows: 24, 36, 48, 72, and 96 hours after start of infusion, and on Days 7, 10, 13, 16, 19, 22, 29, 43 and 57
Population: Pharmacodynamic Per Protocol Set (PD-PPS) was a subset of the Safety Set (SS) which included study participants who had no IPDs affecting the PD variables, as confirmed during a pre-analysis review of the data prior to database lock.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1: Syringe Driver- RLZ Dose 1 (>=35 kg to <50 kg) | Time to Minimum IgG Level (Tmin) of a Single Dose Rozanolixizumab or Placebo | 12.08 days |
| Cohort 1: Syringe Driver- PBO (>=35 kg to <50 kg) | Time to Minimum IgG Level (Tmin) of a Single Dose Rozanolixizumab or Placebo | NA days |
| Cohort 2: Manual Push- RLZ Dose 2 (>=35 kg to <50 kg) | Time to Minimum IgG Level (Tmin) of a Single Dose Rozanolixizumab or Placebo | 11.07 days |
| Cohort 2: Manual Push- PBO (>=35 kg to <50 kg) | Time to Minimum IgG Level (Tmin) of a Single Dose Rozanolixizumab or Placebo | NA days |
| Cohort 3: Syringe Driver- RLZ Dose 1 (>=50 kg) | Time to Minimum IgG Level (Tmin) of a Single Dose Rozanolixizumab or Placebo | 9.012 days |
| Cohort 3: Syringe Driver- PBO (>=50 kg) | Time to Minimum IgG Level (Tmin) of a Single Dose Rozanolixizumab or Placebo | NA days |
| Cohort 4: Manual Push- RLZ Dose 1 (>=50 kg) | Time to Minimum IgG Level (Tmin) of a Single Dose Rozanolixizumab or Placebo | 10.55 days |
| Cohort 4: Manual Push- PBO (>=50 kg) | Time to Minimum IgG Level (Tmin) of a Single Dose Rozanolixizumab or Placebo | NA days |