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This randomized study will evaluate the safety, tolerability and pharmacokinetics of single ascending subcutaneously administered doses of RO7062931 in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RO7062931 0.3mg/kg | Experimental | Participants will receive subcutaneously (SC) 0.3 milligram per kilogram (mg/kg) of RO7062931. |
|
| RO7062931 1.0mg/kg | Experimental | Participants will receive subcutaneously (SC) 1.0 milligram per kilogram (mg/kg) of RO7062931. |
|
| RO7062931 2.0mg/kg | Experimental | Participants will receive subcutaneously (SC) 2.0 milligram per kilogram (mg/kg) of RO7062931. |
|
| RO7062931 4.0mg/kg | Experimental | Participants will receive subcutaneously (SC) 4.0 milligram per kilogram (mg/kg) of RO7062931. |
|
| Placebo | Placebo Comparator | Participants will receive matching placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RO7062931 | Drug | RO7062931 will be administered SC in single ascending doses with starting of 0.3 mg/kg and subsequent doses of 1.0 mg/kg, 2.0 mg/kg and 3.0 mg/kg, respectively. Additional (optional) dose of 4.0 mg/kg may be administered based on safety, tolerability and PK data. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adverse Events and AEs of Special Interest | Adverse events of special interest for this study include the following:
| Up to 16 weeks |
| Percentage of Participants With Marked Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation and Urinalysis Test Results | Marked reference range has been predefined for each laboratory parameter. The marked reference range is broader than the standard reference range. Values falling outside the marked reference range that also represent a defined change from baseline will be considered marked laboratory abnormalities (i.e., potentially clinically relevant). If a baseline value is not available for a study subject, the midpoint of the standard reference range will be used as the study participant baseline value for the purposes of determining marked laboratory abnormalities. | Baseline, Day 2, 8, 15, 29, 85 |
| Percentage of Participants With Electrocardiogram (ECG) Abnormalities | Table entries provide the percentage of Participants with a during treatment assessment abnormality in the direction specified regardless of this abnormality at baseline. Abnormalities reported in Participants with missing baseline values are included. Baseline is the Participant's last observation prior to initiation of study drug. | Baseline; pre-dose, 1 hour (h), 4, 8, 12h post-dose Day 1, 24h post-dose Day 2, 8, 15, 29, 85 |
| Percentage of Participants With T-wave Abnormalities | Table entries provide the percentage of Participants with a during treatment assessment abnormality in the direction specified regardless of this abnormality at baseline. Abnormalities reported in Participants with missing baseline values are included. Baseline is the Participant's last observation prior to initiation of study drug. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) for RO7062931 | Observed Maximum Plasma Concentration were obtained after the participants received the RO7062931 | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18h post-dose Day 1, 24, 30, 36h post-dose Day 2, Day 3, 4, 5, 6, 8 |
| Time to Reach Maximum Plasma Concentration (Tmax) for RO7062931 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Mary Hospital | Hong Kong | Hong Kong | ||||
| Prince of Wales Hospital |
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Planned: Up to 50 healthy volunteers (HVs) across 5 cohorts of 10 HVs (8 active, 2 placebo) per dose-level.
Actual: A total of 41 HVs were enrolled across 4 dose cohorts.
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| ID | Title | Description |
|---|---|---|
| FG000 | RO7062931 0.3mg/kg | Participants will receive subcutaneously (SC) 0.3 milligram per kilogram (mg/kg) of RO7062931. |
| FG001 | RO7062931 1.0mg/kg | Participants will receive subcutaneously (SC) 1.0 milligram per kilogram (mg/kg) of RO7062931. |
| FG002 | RO7062931 2.0mg/kg | Participants will receive subcutaneously (SC) 2.0 milligram per kilogram (mg/kg) of RO7062931. |
| FG003 | RO7062931 4.0mg/kg | Participants will receive subcutaneously (SC) 4.0 milligram per kilogram (mg/kg) of RO7062931. |
| FG004 | Placebo | Participants will receive matching placebo. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | RO7062931 0.3mg/kg | Participants will receive subcutaneously (SC) 0.3 milligram per kilogram (mg/kg) of RO7062931. |
| BG001 | RO7062931 1.0mg/kg | Participants will receive subcutaneously (SC) 1.0 milligram per kilogram (mg/kg) of RO7062931. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Percentage of Participants With Adverse Events and AEs of Special Interest | Adverse events of special interest for this study include the following:
| The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. | Posted | Number | Percentage of Participants | Up to 16 weeks |
|
Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
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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 | RO7062931 0.3mg/kg | Participants will receive subcutaneously (SC) 0.3 milligram per kilogram (mg/kg) of RO7062931. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA version 22.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800-821-8590 | genentech@druginfo.com |
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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 | Nov 29, 2017 | Jul 14, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| C000721064 | RO7062931 |
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|
| Placebo | Drug | Matching placebo will be administered subcutaneously (SC). |
|
| Baseline; pre-dose, 1 hour (h), 4, 8, 12h post-dose Day 1, 24h post-dose Day 2, 8, 15, 29, 85 |
| Percentage of Participants With U-wave Abnormalities | Table entries provide the percentage of Participants with a during treatment assessment abnormality in the direction specified regardless of this abnormality at baseline. Abnormalities reported in Participants with missing baseline values are included. Baseline is the Participant's last observation prior to initiation of study drug. | Baseline; pre-dose, 1 hour (h), 4, 8, 12h post-dose Day 1, 24h post-dose Day 2, 8, 15, 29, 85 |
Time to reach the observed Maximum Plasma Concentration were obtained after the participants received the RO7062931. |
| Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18h post-dose Day 1, 24, 30, 36h post-dose Day 2, Day 3, 4, 5, 6, 8 |
| Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) for RO7062931 | Area Under the Plasma Concentration-time Curve Extrapolated to infinity was calculated based on Non-Compartment Analysis. | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18h post-dose Day 1, 24, 30, 36h post-dose Day 2, Day 3, 4, 5, 6, 8 |
| Area Under the Plasma Concentration-Time Curve From Time Zero Until the Last Quantifiable Time-Point (AUC0-last) for RO7062931 | Area Under the Plasma Concentration-time Curve up to the last measurable concentration was calculated based on Non-Compartment Analysis | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18h post-dose Day 1, 24, 30, 36h post-dose Day 2, Day 3, 4, 5, 6, 8 |
| Terminal Elimination Half-Life (t1/2) for RO7062931 | Terminal Half-life was calculated based on Non-Compartment Analysis. | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18h post-dose Day 1, 24, 30, 36h post-dose Day 2, Day 3, 4, 5, 6, 8 |
| Apparent Clearance (CL/F) for RO7062931 | Apparent oral clearance was calculated from Dose/AUCinf. | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18h post-dose Day 1, 24, 30, 36h post-dose Day 2, Day 3, 4, 5, 6, 8 |
| Apparent Volume of Distribution (Vz/F) for RO7062931 | Apparent volume of distribution was calculated from Dose/AUCinf | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18h post-dose Day 1, 24, 30, 36h post-dose Day 2, Day 3, 4, 5, 6, 8 |
| Cumulative Amount of RO7062931 Excreted in Urine (Ae) | Ae: cumulative amount of drug excreted in urine over a 24 hour period or over defined time periods linked to the pools of urine collected. | (0-4), (4-8), (8-12), (12-24)h post-dose Day 1 |
| Fraction of Cumulative Amount of RO7062931 Excreted in the Urine Over Total Dose (Fe) | The fraction of cumulative amount in urine were calculated based on Ae/Dose | 0-24h h post-dose Day 1 |
| Shatin, New Territories |
| Hong Kong |
| BG002 | RO7062931 2.0mg/kg | Participants will receive subcutaneously (SC) 2.0 milligram per kilogram (mg/kg) of RO7062931. |
| BG003 | RO7062931 4.0mg/kg | Participants will receive subcutaneously (SC) 4.0 milligram per kilogram (mg/kg) of RO7062931. |
| BG004 | Placebo | Participants will receive matching placebo. |
| BG005 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| RO7062931 1.0mg/kg |
Participants will receive subcutaneously (SC) 1.0 milligram per kilogram (mg/kg) of RO7062931. |
| OG002 | RO7062931 2.0mg/kg | Participants will receive subcutaneously (SC) 2.0 milligram per kilogram (mg/kg) of RO7062931. |
| OG003 | RO7062931 4.0mg/kg | Participants will receive subcutaneously (SC) 4.0 milligram per kilogram (mg/kg) of RO7062931. |
| OG004 | Placebo | Participants will receive matching placebo. |
|
|
| Primary | Percentage of Participants With Marked Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation and Urinalysis Test Results | Marked reference range has been predefined for each laboratory parameter. The marked reference range is broader than the standard reference range. Values falling outside the marked reference range that also represent a defined change from baseline will be considered marked laboratory abnormalities (i.e., potentially clinically relevant). If a baseline value is not available for a study subject, the midpoint of the standard reference range will be used as the study participant baseline value for the purposes of determining marked laboratory abnormalities. | The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. | Posted | Number | Percentage of Participants | Baseline, Day 2, 8, 15, 29, 85 |
|
|
|
| Primary | Percentage of Participants With Electrocardiogram (ECG) Abnormalities | Table entries provide the percentage of Participants with a during treatment assessment abnormality in the direction specified regardless of this abnormality at baseline. Abnormalities reported in Participants with missing baseline values are included. Baseline is the Participant's last observation prior to initiation of study drug. | The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. | Posted | Number | Percentage of Participants | Baseline; pre-dose, 1 hour (h), 4, 8, 12h post-dose Day 1, 24h post-dose Day 2, 8, 15, 29, 85 |
|
|
|
| Secondary | Maximum Plasma Concentration (Cmax) for RO7062931 | Observed Maximum Plasma Concentration were obtained after the participants received the RO7062931 | The PK analysis population included all healthy volunteers randomized and adherent to the protocol. Participants were excluded if they significantly violated the inclusion/exclusion criteria, deviated significantly from the protocol or if data were unavailable or incomplete. Data presented is only for participants included in the actual analysis | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol/L | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18h post-dose Day 1, 24, 30, 36h post-dose Day 2, Day 3, 4, 5, 6, 8 |
|
|
|
| Secondary | Time to Reach Maximum Plasma Concentration (Tmax) for RO7062931 | Time to reach the observed Maximum Plasma Concentration were obtained after the participants received the RO7062931. | The PK analysis population included all healthy volunteers randomized and adherent to the protocol. Participants were excluded if they significantly violated the inclusion/exclusion criteria, deviated significantly from the protocol or if data were unavailable or incomplete. Data presented is only for participants included in the actual analysis. | Posted | Median | Full Range | h | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18h post-dose Day 1, 24, 30, 36h post-dose Day 2, Day 3, 4, 5, 6, 8 |
|
|
|
| Secondary | Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) for RO7062931 | Area Under the Plasma Concentration-time Curve Extrapolated to infinity was calculated based on Non-Compartment Analysis. | The PK analysis population included all healthy volunteers randomized and adherent to the protocol. Participants were excluded if they significantly violated the inclusion/exclusion criteria, deviated significantly from the protocol or if data were unavailable or incomplete. Data presented is only for participants included in the actual analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*nmol/L | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18h post-dose Day 1, 24, 30, 36h post-dose Day 2, Day 3, 4, 5, 6, 8 |
|
|
|
| Secondary | Area Under the Plasma Concentration-Time Curve From Time Zero Until the Last Quantifiable Time-Point (AUC0-last) for RO7062931 | Area Under the Plasma Concentration-time Curve up to the last measurable concentration was calculated based on Non-Compartment Analysis | The PK analysis population included all healthy volunteers randomized and adherent to the protocol. Participants were excluded if they significantly violated the inclusion/exclusion criteria, deviated significantly from the protocol or if data were unavailable or incomplete. Data presented is only for participants included in the actual analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*nmol/L | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18h post-dose Day 1, 24, 30, 36h post-dose Day 2, Day 3, 4, 5, 6, 8 |
|
|
|
| Secondary | Terminal Elimination Half-Life (t1/2) for RO7062931 | Terminal Half-life was calculated based on Non-Compartment Analysis. | The PK analysis population included all healthy volunteers randomized and adherent to the protocol. Participants were excluded if they significantly violated the inclusion/exclusion criteria, deviated significantly from the protocol or if data were unavailable or incomplete. Data presented is only for participants included in the actual analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | h | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18h post-dose Day 1, 24, 30, 36h post-dose Day 2, Day 3, 4, 5, 6, 8 |
|
|
|
| Secondary | Apparent Clearance (CL/F) for RO7062931 | Apparent oral clearance was calculated from Dose/AUCinf. | The PK analysis population included all healthy volunteers randomized and adherent to the protocol. Participants were excluded if they significantly violated the inclusion/exclusion criteria, deviated significantly from the protocol or if data were unavailable or incomplete. Data presented is only for participants included in the actual analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | L/h | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18h post-dose Day 1, 24, 30, 36h post-dose Day 2, Day 3, 4, 5, 6, 8 |
|
|
|
| Secondary | Apparent Volume of Distribution (Vz/F) for RO7062931 | Apparent volume of distribution was calculated from Dose/AUCinf | The PK analysis population included all healthy volunteers randomized and adherent to the protocol. Participants were excluded if they significantly violated the inclusion/exclusion criteria, deviated significantly from the protocol or if data were unavailable or incomplete. Data presented is only for participants included in the actual analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | L | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18h post-dose Day 1, 24, 30, 36h post-dose Day 2, Day 3, 4, 5, 6, 8 |
|
|
|
| Secondary | Cumulative Amount of RO7062931 Excreted in Urine (Ae) | Ae: cumulative amount of drug excreted in urine over a 24 hour period or over defined time periods linked to the pools of urine collected. | The PK analysis population included all healthy volunteers randomized and adherent to the protocol. Participants were excluded if they significantly violated the inclusion/exclusion criteria, deviated significantly from the protocol or if data were unavailable or incomplete. Data presented is only for participants included in the actual analysis. | Posted | Mean | Standard Deviation | nmol | (0-4), (4-8), (8-12), (12-24)h post-dose Day 1 |
|
|
|
| Secondary | Fraction of Cumulative Amount of RO7062931 Excreted in the Urine Over Total Dose (Fe) | The fraction of cumulative amount in urine were calculated based on Ae/Dose | The PK analysis population included all healthy volunteers randomized and adherent to the protocol. Participants were excluded if they significantly violated the inclusion/exclusion criteria, deviated significantly from the protocol or if data were unavailable or incomplete. Data presented is only for participants included in the actual analysis. | Posted | Mean | Standard Deviation | Percentage | 0-24h h post-dose Day 1 |
|
|
|
| Primary | Percentage of Participants With T-wave Abnormalities | Table entries provide the percentage of Participants with a during treatment assessment abnormality in the direction specified regardless of this abnormality at baseline. Abnormalities reported in Participants with missing baseline values are included. Baseline is the Participant's last observation prior to initiation of study drug. | The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. | Posted | Number | Percentage of Participants | Baseline; pre-dose, 1 hour (h), 4, 8, 12h post-dose Day 1, 24h post-dose Day 2, 8, 15, 29, 85 |
|
|
|
| Primary | Percentage of Participants With U-wave Abnormalities | Table entries provide the percentage of Participants with a during treatment assessment abnormality in the direction specified regardless of this abnormality at baseline. Abnormalities reported in Participants with missing baseline values are included. Baseline is the Participant's last observation prior to initiation of study drug. | The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not. | Posted | Number | Percentage of Participants | Baseline; pre-dose, 1 hour (h), 4, 8, 12h post-dose Day 1, 24h post-dose Day 2, 8, 15, 29, 85 |
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| 6 |
| 9 |
| EG001 | RO7062931 1.0mg/kg | Participants will receive subcutaneously (SC) 1.0 milligram per kilogram (mg/kg) of RO7062931. | 0 | 8 | 0 | 8 | 5 | 8 |
| EG002 | RO7062931 2.0mg/kg | Participants will receive subcutaneously (SC) 2.0 milligram per kilogram (mg/kg) of RO7062931. | 0 | 8 | 0 | 8 | 5 | 8 |
| EG003 | RO7062931 4.0mg/kg | Participants will receive subcutaneously (SC) 4.0 milligram per kilogram (mg/kg) of RO7062931. | 0 | 8 | 0 | 8 | 6 | 8 |
| EG004 | Placebo | Participants will receive matching placebo. | 0 | 8 | 0 | 8 | 7 | 8 |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA version 22.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA version 22.0 | Systematic Assessment |
|
| Glossodynia | Gastrointestinal disorders | MedDRA version 22.0 | Systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA version 22.0 | Systematic Assessment |
|
| Noninfective gingivitis | Gastrointestinal disorders | MedDRA version 22.0 | Systematic Assessment |
|
| Tongue cyst | Gastrointestinal disorders | MedDRA version 22.0 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA version 22.0 | Systematic Assessment |
|
| Catheter site bruise | General disorders | MedDRA version 22.0 | Systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA version 22.0 | Systematic Assessment |
|
| Vessel puncture site bruise | General disorders | MedDRA version 22.0 | Systematic Assessment |
|
| Vessel puncture site erythema | General disorders | MedDRA version 22.0 | Systematic Assessment |
|
| Vessel puncture site pain | General disorders | MedDRA version 22.0 | Systematic Assessment |
|
| Vessel puncture site pruritus | General disorders | MedDRA version 22.0 | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA version 22.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA version 22.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA version 22.0 | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA version 22.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA version 22.0 | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA version 22.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA version 22.0 | Systematic Assessment |
|
| Injection related reaction | Injury, poisoning and procedural complications | MedDRA version 22.0 | Systematic Assessment |
|
| Skin laceration | Injury, poisoning and procedural complications | MedDRA version 22.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 22.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 22.0 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA version 22.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA version 22.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA version 22.0 | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA version 22.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.0 | Systematic Assessment |
|
| Sputum discoloured | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.0 | Systematic Assessment |
|
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.0 | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA version 22.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA version 22.0 | 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.
| Neutrophils, Total, Abs, Low |
|
| Triglycerides High |
|
| Heart Rate High |
|
| PR Duration Low |
|
| PR Duration High |
|
| QRS Duration Low |
|
| QRS Duration High |
|
| QT Duration Low |
|
| QT Duration High |
|
| QTcF - Fridericia's Correction Formula Low |
|
| QTcF - Fridericia's Correction Formula High |
|
| Ae 0-24h |
|
| Day 1 / 1H |
|
| Day 1 / 4H |
|
| Day 1 / 8H |
|
| Day 1 / 12H |
|
| Day 2 / 24H |
|
| Day 8 / 168H |
|
| Follow-up Visit Day 15 |
|
| Follow-up Visit Day 29 |
|
| Follow-up Visit Day 85 |
|
| Day 1 / 1H |
|
| Day 1 / 4H |
|
| Day 1 / 8H |
|
| Day 1 / 12H |
|
| Day 2 / 24H |
|
| Day 8 / 168H |
|
| Follow-up Visit Day 15 |
|
| Follow-up Visit Day 29 |
|
| Follow-up Visit Day 85 |
|