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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 <50 kg | Experimental | Study participants randomized to Cohort 1 will receive a single dose of rozanolixizumab (RLZ) or placebo (PBO) subcutaneously administered with a syringe driver. |
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| Cohort 2 <50 kg | Experimental | Study participants randomized to Cohort 2 will receive a single dose of rozanolixizumab (RLZ) or placebo (PBO) subcutaneously administered by manual push. |
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| Cohort 3 >=50 kg | Experimental | Study participants randomized to Cohort 3 will receive a single dose of rozanolixizumab (RLZ) or placebo (PBO) subcutaneously administered with a syringe driver. |
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| Cohort 4 >=50 kg | Experimental | Study participants randomized to Cohort 4 will receive a single dose of rozanolixizumab (RLZ) or placebo (PBO) subcutaneously administered by manual push. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rozanolixizumab | Drug | Study participants will receive a single dose rozanolixizumab subcutaneously administered by manual push or a syringe driver. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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 |
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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 |
|---|---|---|---|---|---|---|
| Up0106 001 | London | United Kingdom |
Due to the small sample size in this trial, IPD cannot be adequately anonymized i.e., there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.
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The Participant Flow refers to the Randomized Set.
The study started to enroll participants in April 2021 and concluded in April 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Cohort 1: Syringe Driver- PBO (>=35 kg to <50 kg) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Jun 3, 2021 | Jul 27, 2023 |
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This is a participant-blind and investigator-blind study.
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| Placebo | Other | Study participants will receive a single dose placebo subcutaneously administered by manual push or a syringe driver. |
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| Time to Maximum Plasma Concentration (Tmax) of a Single Dose Rozanolixizumab | tmax was the time to maximum plasma concentration 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 |
| 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. | 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 |
| 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. | 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 |
| 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. | 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 |
| 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. | 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 |
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. |
| FG002 | 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. |
| FG003 | 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. |
| FG004 | 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. |
| FG005 | 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. |
| FG006 | 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. |
| FG007 | 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. |
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Baseline Characteristics refer to the Safety Analysis Set which consisted of all randomized study participants who received investigational medicinal product (IMP).
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | 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. |
| BG005 | 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. |
| BG006 | 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. |
| BG007 | 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. |
| BG008 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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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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| 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 | 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. | The Safety Analysis Set (SS) included all randomized study participants who received IMP. | Posted | Number | percentage of participants | From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57) |
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| 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). | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | ug/mL/mg | 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 |
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| 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. | 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. | Posted | Median | Full Range | hours | 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 |
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| 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours*ug/mL/mg | 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 |
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| 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. | 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. | Posted | Mean | Standard Deviation | grams*day/Litre (g*day/L) | 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 |
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| 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. | 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. | Posted | Mean | Standard Deviation | percent max decrease in total plasma IgG | 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 |
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| 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. | 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. | Posted | Median | Full Range | days | 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 |
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From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
A TEAE was defined as any AE with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication (termination or Withdrawal Visit). The Safety Analysis Set (SS) consisted of all randomized study participants who received IMP.
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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 | 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. | 0 | 6 | 0 | 6 | 5 | 6 |
| EG001 | 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. | 0 | 2 | 0 | 2 | 1 | 2 |
| EG002 | 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. | 0 | 6 | 0 | 6 | 6 | 6 |
| EG003 | 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. | 0 | 2 | 0 | 2 | 1 | 2 |
| EG004 | 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. | 0 | 6 | 0 | 6 | 5 | 6 |
| EG005 | 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. | 0 | 2 | 0 | 2 | 0 | 2 |
| EG006 | 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. | 0 | 6 | 0 | 6 | 5 | 6 |
| EG007 | 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. | 0 | 2 | 0 | 2 | 2 | 2 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA v 24.0 | Non-systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA v 24.0 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA v 24.0 | Non-systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA v 24.0 | Non-systematic Assessment |
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| Gingival bleeding | Gastrointestinal disorders | MedDRA v 24.0 | Non-systematic Assessment |
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| Hypoaesthesia oral | Gastrointestinal disorders | MedDRA v 24.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA v 24.0 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA v 24.0 | Non-systematic Assessment |
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| Infusion site erythema | General disorders | MedDRA v 24.0 | Non-systematic Assessment |
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| Infusion site pain | General disorders | MedDRA v 24.0 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA v 24.0 | Non-systematic Assessment |
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| Infusion site bruising | General disorders | MedDRA v 24.0 | Non-systematic Assessment |
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| Infusion site swelling | General disorders | MedDRA v 24.0 | Non-systematic Assessment |
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| Infusion site pruritus | General disorders | MedDRA v 24.0 | Non-systematic Assessment |
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| Seasonal allergy | Immune system disorders | MedDRA v 24.0 | Non-systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA v 24.0 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA v 24.0 | Non-systematic Assessment |
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| Nerve injury | Injury, poisoning and procedural complications | MedDRA v 24.0 | Non-systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA v 24.0 | Non-systematic Assessment |
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| Occult blood positive | Investigations | MedDRA v 24.0 | Non-systematic Assessment |
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| Respiratory rate decreased | Investigations | MedDRA v 24.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA v 24.0 | Non-systematic Assessment |
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| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA v 24.0 | Non-systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v 24.0 | Non-systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v 24.0 | Non-systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA v 24.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB | Cares | 001 844 599 2273 | UCBCares@ucb.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 1, 2021 | Jul 27, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| C000627812 | rozanolixizumab |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Black or African American |
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| White |
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| Other or Mixed |
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| Not Hispanic or Latino |
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| OG002 |
| 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. |
| OG003 | 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. |
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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. |
| OG003 | 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. |
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| OG002 |
| 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. |
| OG003 | 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. |
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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. |
| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
| OG006 | 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. |
| OG007 | 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. |
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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.
| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
| OG006 | 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. |
| OG007 | 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. |
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| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
| OG006 | 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. |
| OG007 | 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. |
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