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This study was early terminated by the sponsor considering the difficulty of subject recruitment in the pandemic of COVID-19.
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This study will be performed in healthy volunteers in a conventional 3+3 dose-escalation design.
Four cohorts (dose level A, B, C, and D) of up to 6 evaluable volunteers per cohort are planned to be sequentially accrued to receive Careseng 1370 1, 2, and 3 sachets per day, 4,000 mg/sachet before meal (starting from 1 sachet). At least 5 days of staggering and with the investigator's judgement of no safety concern will be required to administer the next volunteer for the first three volunteers of each cohort. The staggering time is counted from Day 1 of one volunteer to Day 1 of the next volunteer.
Careseng 1370 should be taken around 1 hour before meal. No volunteer is allowed to be assigned to more than 1 dose level. All dose escalation/de-escalation decisions will be made by the Data and Safety Monitoring Board (DSMB).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Careseng 1370 Level A | Experimental | Level A (1 sachet): 1 sachet before breakfast. Careseng 1370 granule 4,000 mg sachet consisted of 652 mg (16.3%, w/w) DS-1370 drug substance powder (dry extracts of Panax notoginseng stems and leaves) |
|
| Careseng 1370 Level B | Experimental | Level B (2 sachets): 1 sachet before breakfast, 1 sachet before lunch. Careseng 1370 granule 4,000 mg sachet consisted of 652 mg (16.3%, w/w) DS-1370 drug substance powder (dry extracts of Panax notoginseng stems and leaves) |
|
| Careseng 1370 Level C | Experimental | Level C (3 sachets): 1 sachet before breakfast, 2 sachets before lunch. Careseng 1370 granule 4,000 mg sachet consisted of 652 mg (16.3%, w/w) DS-1370 drug substance powder (dry extracts of Panax notoginseng stems and leaves) |
|
| Careseng 1370 Level D | Experimental | Level D (1 sachet)(modified cohort): 1 sachet before breakfast on 1st, 3rd and 5th days. Careseng 1370 granule 4,000 mg sachet consisted of 652 mg (16.3%, w/w) DS-1370 drug substance powder (dry extracts of Panax notoginseng stems and leaves) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Careseng 1370 | Drug | Careseng 1370 should be taken around 1 hour before meal. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) and/or Serious Adverse Events (SAEs) | An AE is any untoward medical occurrence in a volunteer or clinical investigation participant administered a study medication and that does not necessarily have a causal relationship with this treatment. Laboratory abnormalities should not be recorded as AE unless determined to be clinically significant by Investigator. A SAE is defined as an AE meeting one of the following conditions:
| Day -14 to Day 22 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With no Change From Baseline to Applicable Post-dosing Visits in Body Weight (kg) | *Baseline will be the value of measurement closest to and before start of IP administration. "Body weight unchanged from Baseline to Day X" indicates that the body weight on Day X minus the body weight at baseline has a 95% confidence interval that includes zero. | Day -14 to Day 22 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Abnormal Immune Profile | Immune profile includes percentages of CD3+, CD3+/CD4+, CD3+/CD8+, CD19+, CD16+/CD56+, and CD4/CD8 ratio | Day -14 to Day 22 |
Inclusion Criteria:
Exclusion Criteria:
Volunteer who has a history or evidence of a medical condition that would expose them to a risk of a significant adverse event or interfere with the assessments of safety or pharmacodynamics variables during the course of the trial, including but not limited to hepatic, renal, respiratory, cardiovascular, endocrine, immune, neurological, musculoskeletal or hematological disease as determined by the clinical judgment of the investigator
Volunteer has received any other investigational agent within 28 days prior to the first dose of study drug
Volunteer has taken or potentially takes any herbal medication/supplements/medicinal food, prescription medication and/or over-the-counter medication within 2 weeks prior to the first dose of study drug
Volunteer has alcohol, caffeine, grapefruit juice, or nicotine consumption within 24 hours prior to the first dose of study drug
Female volunteer of childbearing potential who:
Note:
Acceptable forms include:
Male volunteer with female spouse/partners who are of childbearing potential refuses to adopt at least two forms of birth control (at least one of which must be a barrier method) from Screening visit until Final visit
Known or suspected allergy or hypersensitivity to any ingredients of study product
With history of stroke, myocardial infarction, or Coronary Artery Bypass Graft (CABG) surgery within the last 6 months prior to the screening visit
With history of cardiac failure (NYHA class 2 or above), unstable angina, or life-threatening arrhythmia within the last 6 months prior to the screening visit Note: NYHA = New York Heart Association
With blood pressures as systolic blood pressure < 90 mmHg or > 170 mmHg or diastolic blood pressure < 50 mmHg or > 120 mmHg at eligibility checking
History of psychiatric disorder
History of left ventricular outflow obstruction, such as aortic stenosis and hypertrophic cardiomyopathy
With a history of human immunodeficiency virus (HIV) infection or hepatitis B or C infection
Plan to receive surgery from Screening visit until Final visit
Known or suspected hypersensitivity to any component of Careseng 1370, including components in plants of genus Panax, Tween 80, Kolliphor® P188, Fujicalin, and ginseng flavor
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Medical University Hospital | Taipei | Taiwan |
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After the enrollment for Cohort A and Cohort B was completed, this study was early terminated by the sponsor considering the difficulty of subject recruitment in the pandemic of COVID-19. As a result, no subject was recruited to Cohort C and Cohort D.
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| ID | Title | Description |
|---|---|---|
| FG000 | Careseng 1370 Level A | Level A (1 sachet): 1 sachet before breakfast Careseng 1370: Careseng 1370 should be taken around 1 hour before meal. Careseng 1370 granule 4,000 mg sachet consisted of 652 mg (16.3%, w/w) DS-1370 drug substance powder (dry extracts of Panax notoginseng stems and leaves) |
| FG001 | Careseng 1370 Level B | Level B (2 sachets): 1 sachet before breakfast, 1 sachet before lunch. Careseng 1370: Careseng 1370 should be taken around 1 hour before meal. Careseng 1370 granule 4,000 mg sachet consisted of 652 mg (16.3%, w/w) DS-1370 drug substance powder (dry extracts of Panax notoginseng stems and leaves) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
After the enrollment for Cohort A and Cohort B was completed, this study was early terminated by the sponsor considering the difficulty of subject recruitment in the pandemic of COVID-19. As a result, no subject was recruited to Cohort C and Cohort D.
There was one subject in Cohort B violating exclusion criteria 11 (history of psychiatric disorder) and was considered wrong entry.
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| ID | Title | Description |
|---|---|---|
| BG000 | Careseng 1370 Level A | Level A (1 sachet): 1 sachet before breakfast; Careseng 1370: Careseng 1370 should be taken around 1 hour before meal. |
| BG001 | Careseng 1370 Level B | Level B (2 sachets): 1 sachet before breakfast, 1 sachet before lunch Careseng 1370: Careseng 1370 should be taken around 1 hour before meal. |
| 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 | Number of Participants With Adverse Events (AEs) and/or Serious Adverse Events (SAEs) | An AE is any untoward medical occurrence in a volunteer or clinical investigation participant administered a study medication and that does not necessarily have a causal relationship with this treatment. Laboratory abnormalities should not be recorded as AE unless determined to be clinically significant by Investigator. A SAE is defined as an AE meeting one of the following conditions:
| Volunteers received any Careseng 1370 | Posted | Count of Participants | Participants | Day -14 to Day 22 |
Day -14 to Day 22
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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 | Careseng 1370 Level A | Level A (1 sachet): 1 sachet before breakfast Careseng 1370: Careseng 1370 should be taken around 1 hour before meal. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lipase increased | Investigations | MedDRA version 23.0 | Non-systematic Assessment |
Early termination leading to small numbers of subjects analyzed; wrong entry of one subject in dose level B leading to a skewed population.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Liu | i Cure Biotech Co., Ltd. | +886-955-104-105 | white06041983a@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 18, 2020 | Nov 28, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 8, 2022 | Nov 28, 2023 | SAP_001.pdf |
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| Number of Participants With Clinical Laboratory Abnormalities | The laboratory examinations include Hematology tests (CBC, PT and aPTT), Biochemistry (AST, ALP, ALT, bilirubin, creatinine, BUN, CRP, total protein, r-GT, lipid and electrolytes) and Urinalysis (pH, protein, RBC, WBC and urine cast). *Baseline will be the value of measurement closest to and before start of IP administration. | Day -14 to Day 22 |
| Number of Participants With Vital Signs Abnormalities | Vital signs measurement will consist of systolic/diastolic blood pressure, respiratory rate, pulse rate or heart rate, and body temperature. | Day -14 to Day 22 |
| Number of Participants With Physical Examination Abnormalities | Physical examination will include the following items: general appearance, skin, eyes, ears, nose, throat, head and neck, heart, chest and lungs, abdomen, extremities, lymph nodes, musculoskeletal, neurological and others. | Day -14 to Day 22 |
| Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | Maximum plasma concentration (Cmax) of PPD and its metabolites, M-C1, and M-C2. | Day 2 to Day 8 |
| Participants With Abnormal Sinus Rhythm | Sinus rhythm was measured by 12-lead EKG | Day -14 to Day 22 |
| Significantly Abnormal Ventricular Rate Compared to Baseline | Ventricular rate was measured by EKG. | Day -14 to Day 22 |
| Significantly Abnormal PR, QRS, QT, QTc Intervals Compared to Baseline | PR, QRS, QT and QTc intervals were measured by EKG. | Day -14 to Day 22 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Weight | Mean | Standard Deviation | kg |
|
| Height | Mean | Standard Deviation | cm |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Careseng 1370 Level A | Level A (1 sachet): 1 sachet before breakfast; Careseng 1370: Careseng 1370 should be taken around 1 hour before meal. |
| OG001 | Careseng 1370 Level B | Level B (2 sachets): 1 sachet before breakfast, 1 sachet before lunch Careseng 1370: Careseng 1370 should be taken around 1 hour before meal. |
|
|
| Secondary | Number of Participants With no Change From Baseline to Applicable Post-dosing Visits in Body Weight (kg) | *Baseline will be the value of measurement closest to and before start of IP administration. "Body weight unchanged from Baseline to Day X" indicates that the body weight on Day X minus the body weight at baseline has a 95% confidence interval that includes zero. | Volunteers received any Careseng 1370 After the enrollment for Cohort A and Cohort B was completed, this study was early terminated by the sponsor considering the difficulty of subject recruitment in the pandemic of COVID-19. As a result, no subject was recruited to Cohort C and Cohort D. There was one subject violating exclusion criteria 11 (history of psychiatric disorder) and was considered wrong entry. | Posted | Count of Participants | Participants | Day -14 to Day 22 |
|
|
|
| Secondary | Number of Participants With Clinical Laboratory Abnormalities | The laboratory examinations include Hematology tests (CBC, PT and aPTT), Biochemistry (AST, ALP, ALT, bilirubin, creatinine, BUN, CRP, total protein, r-GT, lipid and electrolytes) and Urinalysis (pH, protein, RBC, WBC and urine cast). *Baseline will be the value of measurement closest to and before start of IP administration. | Volunteers received any Careseng 1370 After the enrollment for Cohort A and Cohort B was completed, this study was early terminated by the sponsor considering the difficulty of subject recruitment in the pandemic of COVID-19. As a result, no subject was recruited to Cohort C and Cohort D. There was one subject violating exclusion criteria 11 (history of psychiatric disorder) and was considered wrong entry. | Posted | Count of Participants | Participants | Day -14 to Day 22 |
|
|
|
| Secondary | Number of Participants With Vital Signs Abnormalities | Vital signs measurement will consist of systolic/diastolic blood pressure, respiratory rate, pulse rate or heart rate, and body temperature. | Volunteers received any Careseng 1370 After the enrollment for Cohort A and Cohort B was completed, this study was early terminated by the sponsor considering the difficulty of subject recruitment in the pandemic of COVID-19. As a result, no subject was recruited to Cohort C and Cohort D. There was one subject violating exclusion criteria 11 (history of psychiatric disorder) and was considered wrong entry. | Posted | Count of Participants | Participants | Day -14 to Day 22 |
|
|
|
| Secondary | Number of Participants With Physical Examination Abnormalities | Physical examination will include the following items: general appearance, skin, eyes, ears, nose, throat, head and neck, heart, chest and lungs, abdomen, extremities, lymph nodes, musculoskeletal, neurological and others. | Volunteers received any Careseng 1370 After the enrollment for Cohort A and Cohort B was completed, this study was early terminated by the sponsor considering the difficulty of subject recruitment in the pandemic of COVID-19. As a result, no subject was recruited to Cohort C and Cohort D. There was one subject violating exclusion criteria 11 (history of psychiatric disorder) and was considered wrong entry. | Posted | Count of Participants | Participants | Day -14 to Day 22 |
|
|
|
| Secondary | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | Maximum plasma concentration (Cmax) of PPD and its metabolites, M-C1, and M-C2. | Volunteers received any Careseng 1370 After the enrollment for Cohort A and Cohort B was completed, this study was early terminated by the sponsor considering the difficulty of subject recruitment in the pandemic of COVID-19. As a result, no subject was recruited to Cohort C and Cohort D. There was one subject violating exclusion criteria 11 (history of psychiatric disorder) and was considered wrong entry. | Posted | Mean | Standard Deviation | ng/mL | Day 2 to Day 8 |
|
|
|
| Secondary | Participants With Abnormal Sinus Rhythm | Sinus rhythm was measured by 12-lead EKG | Volunteers received any Careseng 1370 After the enrollment for Cohort A and Cohort B was completed, this study was early terminated by the sponsor considering the difficulty of subject recruitment in the pandemic of COVID-19. As a result, no subject was recruited to Cohort C and Cohort D. There was one subject violating exclusion criteria 11 (history of psychiatric disorder) and was considered wrong entry. | Posted | Count of Participants | Participants | Day -14 to Day 22 |
|
|
|
| Secondary | Significantly Abnormal Ventricular Rate Compared to Baseline | Ventricular rate was measured by EKG. | Volunteers received any Careseng 1370 After the enrollment for Cohort A and Cohort B was completed, this study was early terminated by the sponsor considering the difficulty of subject recruitment in the pandemic of COVID-19. As a result, no subject was recruited to Cohort C and Cohort D. There was one subject violating exclusion criteria 11 (history of psychiatric disorder) and was considered wrong entry. | Posted | Mean | Standard Deviation | beats/min | Day -14 to Day 22 |
|
|
|
| Secondary | Significantly Abnormal PR, QRS, QT, QTc Intervals Compared to Baseline | PR, QRS, QT and QTc intervals were measured by EKG. | Volunteers received any Careseng 1370 After the enrollment for Cohort A and Cohort B was completed, this study was early terminated by the sponsor considering the difficulty of subject recruitment in the pandemic of COVID-19. As a result, no subject was recruited to Cohort C and Cohort D. There was one subject violating exclusion criteria 11 (history of psychiatric disorder) and was considered wrong entry. | Posted | Mean | Standard Deviation | msec | Day -14 to Day 22 |
|
|
|
| Other Pre-specified | Number of Participants With Abnormal Immune Profile | Immune profile includes percentages of CD3+, CD3+/CD4+, CD3+/CD8+, CD19+, CD16+/CD56+, and CD4/CD8 ratio | Volunteers received any Careseng 1370 After the enrollment for Cohort A and Cohort B was completed, this study was early terminated by the sponsor considering the difficulty of subject recruitment in the pandemic of COVID-19. As a result, no subject was recruited to Cohort C and Cohort D. There was one subject violating exclusion criteria 11 (history of psychiatric disorder) and was considered wrong entry. | Posted | Count of Participants | Participants | Day -14 to Day 22 |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 3 |
| 6 |
| EG001 | Careseng 1370 Level B | Level B (2 sachets): 1 sachet before breakfast, 1 sachet before lunch Careseng 1370: Careseng 1370 should be taken around 1 hour before meal. | 0 | 7 | 0 | 7 | 5 | 7 |
| Activated partial thromboplastin time prolonged | Investigations | MedDRA version 23.0 | Non-systematic Assessment |
|
| Lymphocyte count decreased | Investigations | MedDRA version 23.0 | Non-systematic Assessment |
|
| Prothrombin time prolonged | Investigations | MedDRA version 23.0 | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA version 23.0 | Non-systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA version 23.0 | Non-systematic Assessment |
|
Not provided
| Body weight unchanged from Baseline to Day 4 |
|
| Body weight unchanged from Baseline to Day 5 (Pre-dose) |
|
| Body weight unchanged from Baseline to Day 6 |
|
| Body weight unchanged from Baseline to Day 12 |
|
| Body weight unchanged from Baseline to Day 22 |
|
| Lymphocyte Count (10^9/L) (Day 2), Clinically Significant Abnormalities |
|
| Lymphocyte Count (10^9/L) (Day 12), Clinically Significant Abnormalities |
|
| International normalized ratio (Day5, 4 hours post dosing), Clinically Significant Abnormalities |
|
| APTT (Day 1, 8 hours post dosing), Clinically Significant Abnormalities |
|
| APTT (Day 2), Clinically Significant Abnormalities |
|
| APTT (Day 3), Clinically Significant Abnormalities |
|
| APTT (Day 4), Clinically Significant Abnormalities |
|
| APTT (Day 5, Pre-dose), Clinically Significant Abnormalities |
|
| APTT (Day 5, 4 hours post dosing), Clinically Significant Abnormalities |
|
| APTT (Day 6), Clinically Significant Abnormalities |
|
| APTT (Day 22), Clinically Significant Abnormalities |
|
| Lipase (U/L) (Day 1, 8 hours post dosing), Clinically Significant Abnormalities |
|
| Lipase (U/L) (Day 3), Clinically Significant Abnormalities |
|
| Lipase (U/L) (Day 6), Clinically Significant Abnormalities |
|
| Lipase (U/L) (Day 22), Clinically Significant Abnormalities |
|
| PPD at Day 3 pre-dose |
|
|
| PPD at Day 4 pre-dose |
|
|
| PPD at Day 5 pre-dose |
|
|
| PPD at Day 5 0.5 hr post-dose |
|
|
| PPD at Day 5 1 hr post-dose |
|
|
| PPD at Day 5 2 hr post-dose |
|
|
| PPD at Day 5 4 hr post-dose |
|
|
| PPD at Day 5 4.5 hr post-dose |
|
|
| PPD at Day 5 5 hr post-dose |
|
|
| PPD at Day 5 6 hr post-dose |
|
|
| PPD at Day 5 7 hr post-dose |
|
|
| PPD at Day 5 8 hr post-dose |
|
|
| PPD at Day 5 9 hr post-dose |
|
|
| PPD at Day 5 10 hr post-dose |
|
|
| PPD at Day 5 12 hr post-dose |
|
|
| PPD at Day 5 16 hr post-dose |
|
|
| PPD at Day 6 |
|
|
| PPD at Day 7 |
|
|
| PPD at Day 8 |
|
|
| M-C1 at Day 2 pre-dose |
|
|
| M-C1 at Day 3 pre-dose |
|
|
| M-C1 at Day 4 pre-dose |
|
|
| M-C1 at Day 5 pre-dose |
|
|
| M-C1 at Day 5 0.5 hr post-dose |
|
|
| M-C1 at Day 5 1 hr post-dose |
|
|
| M-C1 at Day 5 2 hr post-dose |
|
|
| M-C1 at Day 5 4 hr post-dose |
|
|
| M-C1 at Day 5 4.5 hr post-dose |
|
|
| M-C1 at Day 5 5 hr post-dose |
|
|
| M-C1 at Day 5 6 hr post-dose |
|
|
| M-C1 at Day 5 7 hr post-dose |
|
|
| M-C1 at Day 5 8 hr post-dose |
|
|
| M-C1 at Day 5 9 hr post-dose |
|
|
| M-C1 at Day 5 10 hr post-dose |
|
|
| M-C1 at Day 5 12 hr post-dose |
|
|
| M-C1 at Day 5 16 hr post-dose |
|
|
| M-C1 at Day 6 |
|
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| M-C1 at Day 7 |
|
|
| M-C1 at Day 8 |
|
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| M-C2 at Day 2 pre-dose |
|
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| M-C2 at Day 3 pre-dose |
|
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| M-C2 at Day 4 pre-dose |
|
|
| M-C2 at Day 5 pre-dose |
|
|
| M-C2 at Day 5 0.5 hr post-dose |
|
|
| M-C2 at Day 5 1 hr post-dose |
|
|
| M-C2 at Day 5 2 hr post-dose |
|
|
| M-C2 at Day 5 4 hr post-dose |
|
|
| M-C2 at Day 5 4.5 hr post-dose |
|
|
| M-C2 at Day 5 5 hr post-dose |
|
|
| M-C2 at Day 5 6 hr post-dose |
|
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| M-C2 at Day 5 7 hr post-dose |
|
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| M-C2 at Day 5 8 hr post-dose |
|
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| M-C2 at Day 5 9 hr post-dose |
|
|
| M-C2 at Day 5 10 hr post-dose |
|
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| M-C2 at Day 5 12 hr post-dose |
|
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| M-C2 at Day 5 16 hr post-dose |
|
|
| M-C2 at Day 6 |
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| M-C2 at Day 7 |
|
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| M-C2 at Day 8 |
|
|
| Day 1, 4 hour post dosing |
|
| Day 1, 8 hour post dosing |
|
| Day 1, 12 hour post dosing |
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| Day 2, pre-dose |
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| Day 2, 1 hour post dosing |
|
| Day 3, pre-dose |
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| Day 3, 1 hour post dosing |
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| Day 4, pre-dose |
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| Day 4, 1 hour post dosing |
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| Day 5, pre-dose |
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| Day 5, 1 hour post dosing |
|
| Day 5, 4 hours post dosing |
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| Day 5, 8 hours post dosing |
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| Day 5, 12 hours post dosing |
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| Day 6 |
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| Day 12 |
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| Day 22 |
|
| Day 5, 4 hours post dosing - Baseline |
|
| Day 5, 8 hours post dosing - Baseline |
|
| Day 5, 12 hours post dosing - Baseline |
|
| Day 12 - Baseline |
|
| PR Interval (msec) (Day 2, Pre-dose - Baseline) |
|
| PR Interval (msec) (Day 5, Pre-dose - Baseline) |
|
| PR Interval (msec) (Day 5, 4 hours post dosing - Baseline) |
|
| QRS Interval (msec) (Day 12 - Baseline) |
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| QT Interval (msec) (Day 1, 8 hours post dosing - Baseline) |
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| QT Interval (msec) (Day 5, 12 hours post dosing - Baseline) |
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| QT Interval (msec) (Day 12 - Baseline) |
|
| QTc Interval (msec) (Day 1, 4 hours post dosing - Baseline) |
|
| QTc Interval (msec) (Day 1, 12 hours post dosing - Baseline) |
|
| QTc Interval (msec) (Day 3, Pre-dose - Baseline) |
|
| QTc Interval (msec) (Day 4, Pre-dose - Baseline) |
|
| QTc Interval (msec) (Day 6 - Baseline) |
|
| CD3+/CD8+ (%) |
|
| CD19+ (%) |
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| D16+/CD56+ (%) |
|
| CD4/CD8 Ratio |
|