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Study BP41192 is a randomized, adaptive, placebo-controlled parallel group study to investigate the safety, tolerability, immunogenicity and pharmacokinetics of single-ascending intravenous (IV) doses of RO7126209 in healthy participants. RO7126209 is being developed for the treatment of Alzheimer's Disease.
This study uses a parallel group design, with participants recruited in 5 planned sequential cohorts. Additional cohort(s) may be added if dose escalation stopping criteria are not met after cohort 5. Participants will receive a single IV dose of either RO7126209 or placebo. RO7126209 doses will be administered in ascending order. After the starting dose, subsequent doses will be selected in an adaptive manner during study conduct based on emerging safety, tolerability and PK data.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | In Cohorts 1-5, there were ten participants in total who received placebo, two in each cohort. |
|
| RO7126209 (0.1 mg/kg) | Experimental | Healthy volunteers will be administered a single intravenous dose of RO7126209 (0.1 mg/kg). |
|
| RO7126209 (0.4 mg/kg) | Experimental | Healthy volunteers will be administered a single intravenous dose of RO7126209 (0.4 mg/kg). |
|
| RO7126209 (1.2 mg/kg) | Experimental | Healthy volunteers will be administered a single intravenous dose of RO7126209 (1.2 mg/kg). |
|
| RO7126209 (3.6 mg/kg) | Experimental | Healthy volunteers will be administered a single intravenous dose of RO7126209 (3.6 mg/kg). |
|
| RO7126209 (7.2 mg/kg) | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RO7126209 | Drug | Participants will be administered single-ascending intravenous doses of RO7126209 with at least 2 weeks between each dose level. After the starting dose, the subsequent doses will be selected in an adaptive design. Sentinel dosing will be employed. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adverse Events (AEs) | An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An Adverse Event can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as Adverse Events. | Up to approximately 9 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration at the End of Infusion (Cend) of RO7126209 | Plasma concentrations of RO7126209 were measured by a specific and validated assay at specified timepoints. Plasma PK parameters of RO7126209 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods. Geometric Mean and Coefficient of Variation data are presented below. | Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PRA Health Sciences | Raleigh | North Carolina | 27612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40568753 | Derived | Muliaditan M, van Steeg TJ, Avery LB, Sun W, Hammond TR, Hijdra D, Choi SL, Pillai N, Leksa NC, Mavroudis PD. Translational minimal physiologically based pharmacokinetic model for transferrin receptor-mediated brain delivery of antibodies. MAbs. 2025 Dec;17(1):2515414. doi: 10.1080/19420862.2025.2515414. Epub 2025 Jun 26. |
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Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).
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A total of 36 participants were enrolled at 1 site in the US, out of which 26 participants received active treatment while 10 received placebo.
The study was conducted at 1 center in 1 country.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | In Cohorts 1-5, there were ten participants in total who received placebo, two in each cohort. |
| FG001 | RO7126209 (0.1 mg/kg) | Healthy volunteers were administered a single intravenous dose of RO7126209 (0.1 mg/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_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 31, 2020 |
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Healthy volunteers will be administered a single intravenous dose of RO7126209 (7.2 mg/kg). |
|
| Placebo | Drug | Participants will be administered a single intravenous dose of matching placebo. |
|
| Area Under the Plasma Concentration Versus Time Curve From Zero to 24 h Postdose (AUC0-24h) of RO7126209 | Plasma concentrations of RO7126209 were measured by a specific and validated assay. Plasma PK parameters of RO7126209 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods. Geometric Mean and Coefficient of Variation data are presented below. | Days 1 and 2 |
| Area Under the Plasma Concentration Versus Time Curve From Zero to 168h Postdose (AUC0-168h) of RO7126209 | Plasma concentrations of RO7126209 were measured by a specific and validated assay. Plasma PK parameters of RO7126209 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods. Geometric Mean and Coefficient of Variation data are presented below. | Days 1, 2, 3, 4, 5 and 8 |
| Area Under the Plasma Concentration Versus Time Curve From Zero to the Last Measurable Concentration (AUC0-last) of RO7126209 | Plasma concentrations of RO7126209 were measured by a specific and validated assay. Plasma PK parameters of RO7126209 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods. Geometric Mean and Coefficient of Variation data are presented below. | Days 1, 2, 3, 4, 5, 8, 10, 15, 22, 29, 43 and 57 |
| Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUC0-inf) | Plasma concentrations of RO7126209 were measured by a specific and validated assay. Plasma PK parameters of RO7126209 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods. Geometric Mean and Coefficient of Variation data are presented below. | Days 1, 2, 3, 4, 5, 8, 10, 15, 22, 29, 43 and 57 |
| Terminal Rate Constant (Lambda z) of RO7126209 | Plasma concentrations of RO7126209 were measured by a specific and validated assay. Plasma PK parameters of RO7126209 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods. Geometric Mean and Coefficient of Variation data are presented below. | Days 1, 2, 3, 4, 5, 8, 10, 15, 22, 29, 43 and 57 |
| Apparent Terminal Half-Life (T1/2) of RO7126209 | Plasma concentrations of RO7126209 were measured by a specific and validated assay. Plasma PK parameters of RO7126209 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods. Geometric Mean and Coefficient of Variation data are presented below. | Days 1, 2, 3, 4, 5, 8, 10, 15, 22, 29, 43 and 57 |
| Total Body Clearance Calculated as Dose/AUC (CL) of RO7126209 | Plasma concentrations of RO7126209 were measured by a specific and validated assay. Plasma PK parameters of RO7126209 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods. Geometric Mean and Coefficient of Variation data are presented below. | Days 1, 2, 3, 4, 5, 8, 10, 15, 22, 29, 43 and 57 |
| Volume of Distribution at Steady-State (Vss) of RO7126209 | Plasma concentrations of RO7126209 were measured by a specific and validated assay. Plasma PK parameters of RO7126209 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods. Geometric Mean and Coefficient of Variation data are presented below. | Days 1, 2, 3, 4, 5, 8, 10, 15, 22, 29, 43 and 57 |
| Cerebrospinal Fluid (CSF) Concentration of RO7126209 | RO7126209 CSF concentrations were measured by a specific and validated method. Geometric Mean and Coefficient of Variation data are presented below. | Day 3 and Day 5 |
| Percentage of Participants With Anti-RO7126209 Antibodies (ADAs) | The numbers and proportions of Anti-Drug Antibody (ADA) positive participants and ADA negative participants at baseline (baseline prevalence) and after study drug administration (post-baseline incidence during both the treatment and follow-up periods) were summarized per dose group during both the treatment and follow-up period. | Days 1, 8, 29 and 57 |
| FG002 | RO7126209 (0.4 mg/kg) | Healthy volunteers were administered a single intravenous dose of RO7126209 (0.4 mg/kg). |
| FG003 | RO7126209 (1.2 mg/kg) | Healthy volunteers were administered a single intravenous dose of RO7126209 (1.2 mg/kg). |
| FG004 | RO7126209 (3.6 mg/kg) | Healthy volunteers were administered a single intravenous dose of RO7126209 (3.6 mg/kg). |
| FG005 | RO7126209 (7.2 mg/kg) | Healthy volunteers were administered a single intravenous dose of RO7126209 (7.2 mg/kg). |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | In Cohorts 1-5, there were ten participants in total who received placebo, two in each cohort. |
| BG001 | RO7126209 (0.1 mg/kg) | Healthy volunteers were administered a single intravenous dose of RO7126209 (0.1 mg/kg). |
| BG002 | RO7126209 (0.4 mg/kg) | Healthy volunteers were administered a single intravenous dose of RO7126209 (0.4 mg/kg). |
| BG003 | RO7126209 (1.2 mg/kg) | Healthy volunteers were administered a single intravenous dose of RO7126209 (1.2 mg/kg). |
| BG004 | RO7126209 (3.6 mg/kg) | Healthy volunteers were administered a single intravenous dose of RO7126209 (3.6 mg/kg). |
| BG005 | RO7126209 (7.2 mg/kg) | Healthy volunteers were administered a single intravenous dose of RO7126209 (7.2 mg/kg). |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Ethnicity | Number | Participants |
| |||||||||||||||
| Race/Ethnicity, Customized | Race | Number | Participants |
|
| 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 Adverse Events (AEs) | An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An Adverse Event can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as Adverse Events. | The Safety Population was defined as all participants randomised to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. | Posted | Number | Percentage of Participants | Up to approximately 9 weeks |
|
|
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| Secondary | Concentration at the End of Infusion (Cend) of RO7126209 | Plasma concentrations of RO7126209 were measured by a specific and validated assay at specified timepoints. Plasma PK parameters of RO7126209 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods. Geometric Mean and Coefficient of Variation data are presented below. | The PK Analysis population was defined as all participants who received active (RO7126209) treatment. Participants were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete which could have influenced the PK analysis. Data presented below is only for participants included in the actual analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | µg/mL | Day 1 |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Area Under the Plasma Concentration Versus Time Curve From Zero to 24 h Postdose (AUC0-24h) of RO7126209 | Plasma concentrations of RO7126209 were measured by a specific and validated assay. Plasma PK parameters of RO7126209 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods. Geometric Mean and Coefficient of Variation data are presented below. | The PK Analysis population was defined as all participants who received active (RO7126209) treatment. Participants were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete which could have influenced the PK analysis. Data presented below is only for participants included in the actual analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr.µg/mL | Days 1 and 2 |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Area Under the Plasma Concentration Versus Time Curve From Zero to 168h Postdose (AUC0-168h) of RO7126209 | Plasma concentrations of RO7126209 were measured by a specific and validated assay. Plasma PK parameters of RO7126209 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods. Geometric Mean and Coefficient of Variation data are presented below. | The PK Analysis population was defined as all participants who received active (RO7126209) treatment. Participants were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete which could have influenced the PK analysis. Data presented below is only for participants included in the actual analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr.µg/mL | Days 1, 2, 3, 4, 5 and 8 |
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| Secondary | Area Under the Plasma Concentration Versus Time Curve From Zero to the Last Measurable Concentration (AUC0-last) of RO7126209 | Plasma concentrations of RO7126209 were measured by a specific and validated assay. Plasma PK parameters of RO7126209 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods. Geometric Mean and Coefficient of Variation data are presented below. | The PK Analysis population was defined as all participants who received active (RO7126209) treatment. Participants were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete which could have influenced the PK analysis. Data presented below is only for participants included in the actual analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr.µg/mL | Days 1, 2, 3, 4, 5, 8, 10, 15, 22, 29, 43 and 57 |
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| Secondary | Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUC0-inf) | Plasma concentrations of RO7126209 were measured by a specific and validated assay. Plasma PK parameters of RO7126209 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods. Geometric Mean and Coefficient of Variation data are presented below. | The PK Analysis population was defined as all participants who received active (RO7126209) treatment. Participants were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete which could have influenced the PK analysis. Data presented below is only for participants included in the actual analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr.µg/mL | Days 1, 2, 3, 4, 5, 8, 10, 15, 22, 29, 43 and 57 |
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| Secondary | Terminal Rate Constant (Lambda z) of RO7126209 | Plasma concentrations of RO7126209 were measured by a specific and validated assay. Plasma PK parameters of RO7126209 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods. Geometric Mean and Coefficient of Variation data are presented below. | The PK Analysis population was defined as all participants who received active (RO7126209) treatment. Participants were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete which could have influenced the PK analysis. Data presented below is only for participants included in the actual analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | (1/h) | Days 1, 2, 3, 4, 5, 8, 10, 15, 22, 29, 43 and 57 |
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| Secondary | Apparent Terminal Half-Life (T1/2) of RO7126209 | Plasma concentrations of RO7126209 were measured by a specific and validated assay. Plasma PK parameters of RO7126209 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods. Geometric Mean and Coefficient of Variation data are presented below. | The PK Analysis population was defined as all participants who received active (RO7126209) treatment. Participants were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete which could have influenced the PK analysis. Data presented below is only for participants included in the actual analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr | Days 1, 2, 3, 4, 5, 8, 10, 15, 22, 29, 43 and 57 |
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| Secondary | Total Body Clearance Calculated as Dose/AUC (CL) of RO7126209 | Plasma concentrations of RO7126209 were measured by a specific and validated assay. Plasma PK parameters of RO7126209 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods. Geometric Mean and Coefficient of Variation data are presented below. | The PK Analysis population was defined as all participants who received active (RO7126209) treatment. Participants were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete which could have influenced the PK analysis. Data presented below is only for participants included in the actual analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | mL/hr/kg | Days 1, 2, 3, 4, 5, 8, 10, 15, 22, 29, 43 and 57 |
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| Secondary | Volume of Distribution at Steady-State (Vss) of RO7126209 | Plasma concentrations of RO7126209 were measured by a specific and validated assay. Plasma PK parameters of RO7126209 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods. Geometric Mean and Coefficient of Variation data are presented below. | The PK Analysis population was defined as all participants who received active (RO7126209) treatment. Participants were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete which could have influenced the PK analysis. Data presented below is only for participants included in the actual analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | mL/kg | Days 1, 2, 3, 4, 5, 8, 10, 15, 22, 29, 43 and 57 |
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| Secondary | Cerebrospinal Fluid (CSF) Concentration of RO7126209 | RO7126209 CSF concentrations were measured by a specific and validated method. Geometric Mean and Coefficient of Variation data are presented below. | The PK Analysis population was defined as all participants who received active (RO7126209) treatment. Participants were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete which could have influenced the PK analysis. Data presented below is only for participants included in the actual analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | µg/mL | Day 3 and Day 5 |
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| Secondary | Percentage of Participants With Anti-RO7126209 Antibodies (ADAs) | The numbers and proportions of Anti-Drug Antibody (ADA) positive participants and ADA negative participants at baseline (baseline prevalence) and after study drug administration (post-baseline incidence during both the treatment and follow-up periods) were summarized per dose group during both the treatment and follow-up period. | The Immunogenicity population was defined as all participants who had at least one pre-dose or at least one post dose ADA assessment and were included and analysed according to the treatment they actually received. Data presented below is only for participants included in the actual analysis. | Posted | Number | Percentage of Participants | Days 1, 8, 29 and 57 |
|
Up to approximately 9 weeks
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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 | Placebo | In Cohorts 1-5, there were ten participants in total who received placebo, two in each cohort. | 0 | 10 | 0 | 10 | 8 | 10 |
| EG001 | RO7126209 (0.1 mg/kg) | Healthy volunteers were administered a single intravenous dose of RO7126209 (0.1 mg/kg). | 0 | 4 | 0 | 4 | 3 | 4 |
| EG002 | RO7126209 (0.4 mg/kg) | Healthy volunteers were administered a single intravenous dose of RO7126209 (0.4 mg/kg). | 0 | 4 | 0 | 4 | 2 | 4 |
| EG003 | RO7126209 (1.2 mg/kg) | Healthy volunteers were administered a single intravenous dose of RO7126209 (1.2 mg/kg). | 0 | 6 | 0 | 6 | 5 | 6 |
| EG004 | RO7126209 (3.6 mg/kg) | Healthy volunteers were administered a single intravenous dose of RO7126209 (3.6 mg/kg). | 0 | 6 | 0 | 6 | 6 | 6 |
| EG005 | RO7126209 (7.2 mg/kg) | Healthy volunteers were administered a single intravenous dose of RO7126209 (7.2 mg/kg). | 0 | 6 | 0 | 6 | 6 | 6 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Crepitations | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Injection site extravasation | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the study but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800 821-8590 | genentech@druginfo.com |
| Jun 14, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| Male |
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| Not Hispanic or Latino |
|
| Asian |
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| Black or African American |
|
| White |
|
| Multiple |
|
Healthy volunteers were administered a single intravenous dose of RO7126209 (1.2 mg/kg).
| OG003 | RO7126209 (3.6 mg/kg) | Healthy volunteers were administered a single intravenous dose of RO7126209 (3.6 mg/kg). |
| OG004 | RO7126209 (7.2 mg/kg) | Healthy volunteers were administered a single intravenous dose of RO7126209 (7.2 mg/kg). |
|
|
Healthy volunteers were administered a single intravenous dose of RO7126209 (1.2 mg/kg).
| OG003 | RO7126209 (3.6 mg/kg) | Healthy volunteers were administered a single intravenous dose of RO7126209 (3.6 mg/kg). |
| OG004 | RO7126209 (7.2 mg/kg) | Healthy volunteers were administered a single intravenous dose of RO7126209 (7.2 mg/kg). |
|
|
Healthy volunteers were administered a single intravenous dose of RO7126209 (1.2 mg/kg).
| OG003 | RO7126209 (3.6 mg/kg) | Healthy volunteers were administered a single intravenous dose of RO7126209 (3.6 mg/kg). |
| OG004 | RO7126209 (7.2 mg/kg) | Healthy volunteers were administered a single intravenous dose of RO7126209 (7.2 mg/kg). |
|
|
Healthy volunteers were administered a single intravenous dose of RO7126209 (1.2 mg/kg). |
| OG003 | RO7126209 (3.6 mg/kg) | Healthy volunteers were administered a single intravenous dose of RO7126209 (3.6 mg/kg). |
| OG004 | RO7126209 (7.2 mg/kg) | Healthy volunteers were administered a single intravenous dose of RO7126209 (7.2 mg/kg). |
|
|
Healthy volunteers were administered a single intravenous dose of RO7126209 (1.2 mg/kg). |
| OG003 | RO7126209 (3.6 mg/kg) | Healthy volunteers were administered a single intravenous dose of RO7126209 (3.6 mg/kg). |
| OG004 | RO7126209 (7.2 mg/kg) | Healthy volunteers were administered a single intravenous dose of RO7126209 (7.2 mg/kg). |
|
|
Healthy volunteers were administered a single intravenous dose of RO7126209 (1.2 mg/kg).
| OG003 | RO7126209 (3.6 mg/kg) | Healthy volunteers were administered a single intravenous dose of RO7126209 (3.6 mg/kg). |
| OG004 | RO7126209 (7.2 mg/kg) | Healthy volunteers were administered a single intravenous dose of RO7126209 (7.2 mg/kg). |
|
|
Healthy volunteers were administered a single intravenous dose of RO7126209 (1.2 mg/kg).
| OG003 | RO7126209 (3.6 mg/kg) | Healthy volunteers were administered a single intravenous dose of RO7126209 (3.6 mg/kg). |
| OG004 | RO7126209 (7.2 mg/kg) | Healthy volunteers were administered a single intravenous dose of RO7126209 (7.2 mg/kg). |
|
|
Healthy volunteers were administered a single intravenous dose of RO7126209 (1.2 mg/kg).
| OG003 | RO7126209 (3.6 mg/kg) | Healthy volunteers were administered a single intravenous dose of RO7126209 (3.6 mg/kg). |
| OG004 | RO7126209 (7.2 mg/kg) | Healthy volunteers were administered a single intravenous dose of RO7126209 (7.2 mg/kg). |
|
|
Healthy volunteers were administered a single intravenous dose of RO7126209 (1.2 mg/kg).
| OG003 | RO7126209 (3.6 mg/kg) | Healthy volunteers were administered a single intravenous dose of RO7126209 (3.6 mg/kg). |
| OG004 | RO7126209 (7.2 mg/kg) | Healthy volunteers were administered a single intravenous dose of RO7126209 (7.2 mg/kg). |
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|
| OG003 |
| RO7126209 (3.6 mg/kg) |
Healthy volunteers were administered a single intravenous dose of RO7126209 (3.6 mg/kg). |
| OG004 | RO7126209 (7.2 mg/kg) | Healthy volunteers were administered a single intravenous dose of RO7126209 (7.2 mg/kg). |
|
|
| OG003 | RO7126209 (3.6 mg/kg) | Healthy volunteers were administered a single intravenous dose of RO7126209 (3.6 mg/kg). |
| OG004 | RO7126209 (7.2 mg/kg) | Healthy volunteers were administered a single intravenous dose of RO7126209 (7.2 mg/kg). |
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|
|