Chemotherapy-induced Myelosuppression
Conditions
Brief summary
This study will be performed in healthy volunteers in a conventional 3+3 dose-escalation design.
Detailed description
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).
Interventions
DRUGCareseng 1370
Careseng 1370 should be taken around 1 hour before meal.
Sponsors
i Cure Biotech Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
1. Adult aged between 20-40 years old (inclusive) 2. Physically and mentally healthy volunteer as confirmed by an interview, medical history, clinical examination, chest X-rays, and electrocardiogram. Volunteer with non-clinically significant signs or symptoms may be eligible at investigator's discretion. 3. Body Mass Index (BMI) between 18.5 and 24, inclusive (BMI will be calculated as weight in kilogram \[kg\]/(height in meters)2 \[m2\]) 4. Clinically normal hematology, biochemistry and urinalysis determinations based on investigator's discretion. Volunteer with non-clinically significant signs or symptoms may be eligible at investigator's discretion. 5. Volunteer is willing and able to comply with study procedures and sign informed consent prior to initiation of any study-mandated procedures.
Exclusion criteria
1. 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 2. Volunteer has received any other investigational agent within 28 days prior to the first dose of study drug 3. 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 4. Volunteer has alcohol, caffeine, grapefruit juice, or nicotine consumption within 24 hours prior to the first dose of study drug 5. Female volunteer of childbearing potential who: * is lactating; or * has positive pregnancy test result at eligibility checking; or * refuses to adopt at least two forms of birth control (at least one of which must be a barrier method) from Screening visit to Final visit. Note: Acceptable forms include: 1. Established use of oral, injected or implanted hormonal methods of contraception. 2. Placement of an intrauterine device (IUD) or intrauterine system (IUS). 3. Barrier methods of contraception: Condom OR Occlusive cap (diaphragm or cervical/vault caps) 6. 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 7. Known or suspected allergy or hypersensitivity to any ingredients of study product 8. With history of stroke, myocardial infarction, or Coronary Artery Bypass Graft (CABG) surgery within the last 6 months prior to the screening visit 9. 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 10. With blood pressures as systolic blood pressure \< 90 mmHg or \> 170 mmHg or diastolic blood pressure \< 50 mmHg or \> 120 mmHg at eligibility checking 11. History of psychiatric disorder 12. History of left ventricular outflow obstruction, such as aortic stenosis and hypertrophic cardiomyopathy 13. With a history of human immunodeficiency virus (HIV) infection or hepatitis B or C infection 14. Plan to receive surgery from Screening visit until Final visit 15. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AEs) and/or Serious Adverse Events (SAEs) | Day -14 to Day 22 | 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: * Death during the period of protocol defined surveillance * Life Threatening Event (defined as a participant at immediate risk of death at the time of the event) * An event requiring in volunteer hospitalization or prolongation of existing hospitalization during the period of protocol defined surveillance * Results in congenital anomaly or birth defect * Results in a persistent or significant disability/incapacity * Based upon appropriate medical judgment, the event may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed above. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With no Change From Baseline to Applicable Post-dosing Visits in Body Weight (kg) | Day -14 to Day 22 | \*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. |
| Number of Participants With Clinical Laboratory Abnormalities | Day -14 to Day 22 | 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. |
| Number of Participants With Vital Signs Abnormalities | Day -14 to Day 22 | Vital signs measurement will consist of systolic/diastolic blood pressure, respiratory rate, pulse rate or heart rate, and body temperature. |
| Number of Participants With Physical Examination Abnormalities | Day -14 to Day 22 | 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. |
| Participants With Abnormal Sinus Rhythm | Day -14 to Day 22 | Sinus rhythm was measured by 12-lead EKG |
| Significantly Abnormal Ventricular Rate Compared to Baseline | Day -14 to Day 22 | Ventricular rate was measured by EKG. |
| Significantly Abnormal PR, QRS, QT, QTc Intervals Compared to Baseline | Day -14 to Day 22 | PR, QRS, QT and QTc intervals were measured by EKG. |
| Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | Day 2 to Day 8 | Maximum plasma concentration (Cmax) of PPD and its metabolites, M-C1, and M-C2. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Abnormal Immune Profile | Day -14 to Day 22 | Immune profile includes percentages of CD3+, CD3+/CD4+, CD3+/CD8+, CD19+, CD16+/CD56+, and CD4/CD8 ratio |
Countries
Taiwan
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Careseng 1370 Level A Level A (1 sachet): 1 sachet before breakfast;
Careseng 1370: Careseng 1370 should be taken around 1 hour before meal. | 6 |
| 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. | 7 |
| Total | 13 |
Baseline characteristics
| Characteristic | Total | Careseng 1370 Level A | Careseng 1370 Level B |
|---|---|---|---|
| Age, Continuous | 25.2 years STANDARD_DEVIATION 2.45 | 24.3 years STANDARD_DEVIATION 2.25 | 26.0 years STANDARD_DEVIATION 2.52 |
| BMI | 21.46 kg/m^2 STANDARD_DEVIATION 1.851 | 22.11 kg/m^2 STANDARD_DEVIATION 1.572 | 20.90 kg/m^2 STANDARD_DEVIATION 2.002 |
| Body Weight | 58.9 kg STANDARD_DEVIATION 10.07 | 62.3 kg STANDARD_DEVIATION 11.59 | 55.9 kg STANDARD_DEVIATION 8.31 |
| Height | 164.7 cm STANDARD_DEVIATION 8.52 | 167.3 cm STANDARD_DEVIATION 9.81 | 162.4 cm STANDARD_DEVIATION 7.23 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 13 Participants | 6 Participants | 7 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Taiwan | 13 participants | 6 participants | 7 participants |
| Sex: Female, Male Female | 6 Participants | 4 Participants | 2 Participants |
| Sex: Female, Male Male | 7 Participants | 2 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 7 |
| other Total, other adverse events | 3 / 6 | 5 / 7 |
| serious Total, serious adverse events | 0 / 6 | 0 / 7 |
Outcome results
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: * Death during the period of protocol defined surveillance * Life Threatening Event (defined as a participant at immediate risk of death at the time of the event) * An event requiring in volunteer hospitalization or prolongation of existing hospitalization during the period of protocol defined surveillance * Results in congenital anomaly or birth defect * Results in a persistent or significant disability/incapacity * Based upon appropriate medical judgment, the event may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed above.
Time frame: Day -14 to Day 22
Population: Volunteers received any Careseng 1370
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Careseng 1370 Level A | Number of Participants With Adverse Events (AEs) and/or Serious Adverse Events (SAEs) | Subjects with AE | 3 Participants |
| Careseng 1370 Level A | Number of Participants With Adverse Events (AEs) and/or Serious Adverse Events (SAEs) | Subjects with SAE | 0 Participants |
| Careseng 1370 Level B | Number of Participants With Adverse Events (AEs) and/or Serious Adverse Events (SAEs) | Subjects with AE | 5 Participants |
| Careseng 1370 Level B | Number of Participants With Adverse Events (AEs) and/or Serious Adverse Events (SAEs) | Subjects with SAE | 0 Participants |
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.
Time frame: Day -14 to Day 22
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Careseng 1370 Level A | Number of Participants With Clinical Laboratory Abnormalities | Lymphocyte Count (10^9/L) (Day 12), Clinically Significant Abnormalities | 1 Participants |
| Careseng 1370 Level A | Number of Participants With Clinical Laboratory Abnormalities | APTT (Day 3), Clinically Significant Abnormalities | 1 Participants |
| Careseng 1370 Level A | Number of Participants With Clinical Laboratory Abnormalities | APTT (Day 1, 8 hours post dosing), Clinically Significant Abnormalities | 1 Participants |
| Careseng 1370 Level A | Number of Participants With Clinical Laboratory Abnormalities | APTT (Day 4), Clinically Significant Abnormalities | 1 Participants |
| Careseng 1370 Level A | Number of Participants With Clinical Laboratory Abnormalities | Lymphocytes (%) (Day 2), Clinically Significant Abnormalities | 0 Participants |
| Careseng 1370 Level A | Number of Participants With Clinical Laboratory Abnormalities | APTT (Day 5, Pre-dose), Clinically Significant Abnormalities | 1 Participants |
| Careseng 1370 Level A | Number of Participants With Clinical Laboratory Abnormalities | International normalized ratio (Day5, 4 hours post dosing), Clinically Significant Abnormalities | 1 Participants |
| Careseng 1370 Level A | Number of Participants With Clinical Laboratory Abnormalities | APTT (Day 5, 4 hours post dosing), Clinically Significant Abnormalities | 1 Participants |
| Careseng 1370 Level A | Number of Participants With Clinical Laboratory Abnormalities | APTT (Day 6), Clinically Significant Abnormalities | 1 Participants |
| Careseng 1370 Level A | Number of Participants With Clinical Laboratory Abnormalities | Lymphocytes (%) (Day 12), Clinically Significant Abnormalities | 1 Participants |
| Careseng 1370 Level A | Number of Participants With Clinical Laboratory Abnormalities | APTT (Day 22), Clinically Significant Abnormalities | 1 Participants |
| Careseng 1370 Level A | Number of Participants With Clinical Laboratory Abnormalities | APTT (Day 2), Clinically Significant Abnormalities | 1 Participants |
| Careseng 1370 Level A | Number of Participants With Clinical Laboratory Abnormalities | Lipase (U/L) (Day 1, 8 hours post dosing), Clinically Significant Abnormalities | 0 Participants |
| Careseng 1370 Level A | Number of Participants With Clinical Laboratory Abnormalities | Lymphocyte Count (10^9/L) (Day 2), Clinically Significant Abnormalities | 0 Participants |
| Careseng 1370 Level A | Number of Participants With Clinical Laboratory Abnormalities | Lipase (U/L) (Day 3), Clinically Significant Abnormalities | 0 Participants |
| Careseng 1370 Level A | Number of Participants With Clinical Laboratory Abnormalities | Lipase (U/L) (Day 22), Clinically Significant Abnormalities | 0 Participants |
| Careseng 1370 Level A | Number of Participants With Clinical Laboratory Abnormalities | Lipase (U/L) (Day 6), Clinically Significant Abnormalities | 0 Participants |
| Careseng 1370 Level B | Number of Participants With Clinical Laboratory Abnormalities | Lipase (U/L) (Day 22), Clinically Significant Abnormalities | 1 Participants |
| Careseng 1370 Level B | Number of Participants With Clinical Laboratory Abnormalities | International normalized ratio (Day5, 4 hours post dosing), Clinically Significant Abnormalities | 0 Participants |
| Careseng 1370 Level B | Number of Participants With Clinical Laboratory Abnormalities | APTT (Day 1, 8 hours post dosing), Clinically Significant Abnormalities | 0 Participants |
| Careseng 1370 Level B | Number of Participants With Clinical Laboratory Abnormalities | APTT (Day 2), Clinically Significant Abnormalities | 0 Participants |
| Careseng 1370 Level B | Number of Participants With Clinical Laboratory Abnormalities | APTT (Day 5, 4 hours post dosing), Clinically Significant Abnormalities | 0 Participants |
| Careseng 1370 Level B | Number of Participants With Clinical Laboratory Abnormalities | Lipase (U/L) (Day 3), Clinically Significant Abnormalities | 1 Participants |
| Careseng 1370 Level B | Number of Participants With Clinical Laboratory Abnormalities | Lipase (U/L) (Day 6), Clinically Significant Abnormalities | 2 Participants |
| Careseng 1370 Level B | Number of Participants With Clinical Laboratory Abnormalities | Lymphocytes (%) (Day 2), Clinically Significant Abnormalities | 1 Participants |
| Careseng 1370 Level B | Number of Participants With Clinical Laboratory Abnormalities | Lymphocytes (%) (Day 12), Clinically Significant Abnormalities | 0 Participants |
| Careseng 1370 Level B | Number of Participants With Clinical Laboratory Abnormalities | Lymphocyte Count (10^9/L) (Day 2), Clinically Significant Abnormalities | 1 Participants |
| Careseng 1370 Level B | Number of Participants With Clinical Laboratory Abnormalities | APTT (Day 3), Clinically Significant Abnormalities | 0 Participants |
| Careseng 1370 Level B | Number of Participants With Clinical Laboratory Abnormalities | APTT (Day 4), Clinically Significant Abnormalities | 0 Participants |
| Careseng 1370 Level B | Number of Participants With Clinical Laboratory Abnormalities | APTT (Day 5, Pre-dose), Clinically Significant Abnormalities | 0 Participants |
| Careseng 1370 Level B | Number of Participants With Clinical Laboratory Abnormalities | APTT (Day 6), Clinically Significant Abnormalities | 0 Participants |
| Careseng 1370 Level B | Number of Participants With Clinical Laboratory Abnormalities | APTT (Day 22), Clinically Significant Abnormalities | 0 Participants |
| Careseng 1370 Level B | Number of Participants With Clinical Laboratory Abnormalities | Lipase (U/L) (Day 1, 8 hours post dosing), Clinically Significant Abnormalities | 1 Participants |
| Careseng 1370 Level B | Number of Participants With Clinical Laboratory Abnormalities | Lymphocyte Count (10^9/L) (Day 12), Clinically Significant Abnormalities | 0 Participants |
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.
Time frame: Day -14 to Day 22
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Careseng 1370 Level A | Number of Participants With no Change From Baseline to Applicable Post-dosing Visits in Body Weight (kg) | Body weight unchanged from Baseline to Day 4 | 6 Participants |
| Careseng 1370 Level A | Number of Participants With no Change From Baseline to Applicable Post-dosing Visits in Body Weight (kg) | Body weight unchanged from Baseline to Day 6 | 6 Participants |
| Careseng 1370 Level A | Number of Participants With no Change From Baseline to Applicable Post-dosing Visits in Body Weight (kg) | Body weight unchanged from Baseline to Day 3 | 6 Participants |
| Careseng 1370 Level A | Number of Participants With no Change From Baseline to Applicable Post-dosing Visits in Body Weight (kg) | Body weight unchanged from Baseline to Day 12 | 6 Participants |
| Careseng 1370 Level A | Number of Participants With no Change From Baseline to Applicable Post-dosing Visits in Body Weight (kg) | Body weight unchanged from Baseline to Day 5 (Pre-dose) | 6 Participants |
| Careseng 1370 Level A | Number of Participants With no Change From Baseline to Applicable Post-dosing Visits in Body Weight (kg) | Body weight unchanged from Baseline to Day 22 | 6 Participants |
| Careseng 1370 Level A | Number of Participants With no Change From Baseline to Applicable Post-dosing Visits in Body Weight (kg) | Body weight unchanged from Baseline to Day 2 | 6 Participants |
| Careseng 1370 Level B | Number of Participants With no Change From Baseline to Applicable Post-dosing Visits in Body Weight (kg) | Body weight unchanged from Baseline to Day 22 | 7 Participants |
| Careseng 1370 Level B | Number of Participants With no Change From Baseline to Applicable Post-dosing Visits in Body Weight (kg) | Body weight unchanged from Baseline to Day 2 | 7 Participants |
| Careseng 1370 Level B | Number of Participants With no Change From Baseline to Applicable Post-dosing Visits in Body Weight (kg) | Body weight unchanged from Baseline to Day 3 | 7 Participants |
| Careseng 1370 Level B | Number of Participants With no Change From Baseline to Applicable Post-dosing Visits in Body Weight (kg) | Body weight unchanged from Baseline to Day 4 | 7 Participants |
| Careseng 1370 Level B | Number of Participants With no Change From Baseline to Applicable Post-dosing Visits in Body Weight (kg) | Body weight unchanged from Baseline to Day 5 (Pre-dose) | 7 Participants |
| Careseng 1370 Level B | Number of Participants With no Change From Baseline to Applicable Post-dosing Visits in Body Weight (kg) | Body weight unchanged from Baseline to Day 6 | 7 Participants |
| Careseng 1370 Level B | Number of Participants With no Change From Baseline to Applicable Post-dosing Visits in Body Weight (kg) | Body weight unchanged from Baseline to Day 12 | 7 Participants |
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.
Time frame: Day -14 to Day 22
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Careseng 1370 Level A | Number of Participants With Physical Examination Abnormalities | Extremities (Day 12) | 0 Participants |
| Careseng 1370 Level A | Number of Participants With Physical Examination Abnormalities | Skin (Day 22) | 0 Participants |
| Careseng 1370 Level B | Number of Participants With Physical Examination Abnormalities | Extremities (Day 12) | 1 Participants |
| Careseng 1370 Level B | Number of Participants With Physical Examination Abnormalities | Skin (Day 22) | 1 Participants |
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.
Time frame: Day -14 to Day 22
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Careseng 1370 Level A | Number of Participants With Vital Signs Abnormalities | 0 Participants |
| Careseng 1370 Level B | Number of Participants With Vital Signs Abnormalities | 0 Participants |
Secondary
Participants With Abnormal Sinus Rhythm
Sinus rhythm was measured by 12-lead EKG
Time frame: Day -14 to Day 22
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Careseng 1370 Level A | Participants With Abnormal Sinus Rhythm | Day 5, pre-dose | 4 Participants |
| Careseng 1370 Level A | Participants With Abnormal Sinus Rhythm | Day 1, 1 hour post dosing | 3 Participants |
| Careseng 1370 Level A | Participants With Abnormal Sinus Rhythm | Day 4, pre-dose | 1 Participants |
| Careseng 1370 Level A | Participants With Abnormal Sinus Rhythm | Day 1, 4 hour post dosing | 3 Participants |
| Careseng 1370 Level A | Participants With Abnormal Sinus Rhythm | Day 5, 1 hour post dosing | 4 Participants |
| Careseng 1370 Level A | Participants With Abnormal Sinus Rhythm | Day 1, 8 hour post dosing | 1 Participants |
| Careseng 1370 Level A | Participants With Abnormal Sinus Rhythm | Day 3, 1 hour post dosing | 2 Participants |
| Careseng 1370 Level A | Participants With Abnormal Sinus Rhythm | Day 1, 12 hour post dosing | 1 Participants |
| Careseng 1370 Level A | Participants With Abnormal Sinus Rhythm | Day 5, 4 hours post dosing | 2 Participants |
| Careseng 1370 Level A | Participants With Abnormal Sinus Rhythm | Day 2, pre-dose | 2 Participants |
| Careseng 1370 Level A | Participants With Abnormal Sinus Rhythm | Day 4, 1 hour post dosing | 1 Participants |
| Careseng 1370 Level A | Participants With Abnormal Sinus Rhythm | Day 2, 1 hour post dosing | 1 Participants |
| Careseng 1370 Level A | Participants With Abnormal Sinus Rhythm | Day 5, 8 hours post dosing | 1 Participants |
| Careseng 1370 Level A | Participants With Abnormal Sinus Rhythm | Day 6 | 0 Participants |
| Careseng 1370 Level A | Participants With Abnormal Sinus Rhythm | Day 3, pre-dose | 2 Participants |
| Careseng 1370 Level A | Participants With Abnormal Sinus Rhythm | Day 12 | 0 Participants |
| Careseng 1370 Level A | Participants With Abnormal Sinus Rhythm | Day 5, 12 hours post dosing | 1 Participants |
| Careseng 1370 Level A | Participants With Abnormal Sinus Rhythm | Day 22 | 2 Participants |
| Careseng 1370 Level A | Participants With Abnormal Sinus Rhythm | Baseline | 6 Participants |
| Careseng 1370 Level B | Participants With Abnormal Sinus Rhythm | Day 22 | 0 Participants |
| Careseng 1370 Level B | Participants With Abnormal Sinus Rhythm | Day 3, pre-dose | 0 Participants |
| Careseng 1370 Level B | Participants With Abnormal Sinus Rhythm | Day 3, 1 hour post dosing | 0 Participants |
| Careseng 1370 Level B | Participants With Abnormal Sinus Rhythm | Day 4, pre-dose | 0 Participants |
| Careseng 1370 Level B | Participants With Abnormal Sinus Rhythm | Day 4, 1 hour post dosing | 0 Participants |
| Careseng 1370 Level B | Participants With Abnormal Sinus Rhythm | Day 5, pre-dose | 0 Participants |
| Careseng 1370 Level B | Participants With Abnormal Sinus Rhythm | Day 5, 1 hour post dosing | 0 Participants |
| Careseng 1370 Level B | Participants With Abnormal Sinus Rhythm | Day 5, 4 hours post dosing | 0 Participants |
| Careseng 1370 Level B | Participants With Abnormal Sinus Rhythm | Day 5, 8 hours post dosing | 0 Participants |
| Careseng 1370 Level B | Participants With Abnormal Sinus Rhythm | Baseline | 0 Participants |
| Careseng 1370 Level B | Participants With Abnormal Sinus Rhythm | Day 1, 1 hour post dosing | 0 Participants |
| Careseng 1370 Level B | Participants With Abnormal Sinus Rhythm | Day 1, 4 hour post dosing | 0 Participants |
| Careseng 1370 Level B | Participants With Abnormal Sinus Rhythm | Day 1, 8 hour post dosing | 0 Participants |
| Careseng 1370 Level B | Participants With Abnormal Sinus Rhythm | Day 1, 12 hour post dosing | 0 Participants |
| Careseng 1370 Level B | Participants With Abnormal Sinus Rhythm | Day 2, pre-dose | 0 Participants |
| Careseng 1370 Level B | Participants With Abnormal Sinus Rhythm | Day 5, 12 hours post dosing | 0 Participants |
| Careseng 1370 Level B | Participants With Abnormal Sinus Rhythm | Day 6 | 0 Participants |
| Careseng 1370 Level B | Participants With Abnormal Sinus Rhythm | Day 12 | 0 Participants |
| Careseng 1370 Level B | Participants With Abnormal Sinus Rhythm | Day 2, 1 hour post dosing | 0 Participants |
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.
Time frame: Day 2 to Day 8
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Careseng 1370 Level A | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | M-C2 at Day 5 0.5 hr post-dose | 14.9 ng/mL | Standard Deviation 6.08 |
| Careseng 1370 Level A | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | M-C1 at Day 5 2 hr post-dose | 358 ng/mL | Standard Deviation 97.5 |
| Careseng 1370 Level A | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | PPD at Day 8 | 6.37 ng/mL | Standard Deviation 4.25 |
| Careseng 1370 Level A | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | M-C1 at Day 5 4 hr post-dose | 351 ng/mL | Standard Deviation 180 |
| Careseng 1370 Level A | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | PPD at Day 5 6 hr post-dose | 83.2 ng/mL | Standard Deviation 70.8 |
| Careseng 1370 Level A | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | M-C1 at Day 2 pre-dose | 29.1 ng/mL | Standard Deviation 14.5 |
| Careseng 1370 Level A | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | M-C2 at Day 5 6 hr post-dose | 26.7 ng/mL | Standard Deviation 20.4 |
| Careseng 1370 Level A | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | M-C1 at Day 5 6 hr post-dose | 260 ng/mL | Standard Deviation 131 |
| Careseng 1370 Level A | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | PPD at Day 5 2 hr post-dose | 148 ng/mL | Standard Deviation 73 |
| Careseng 1370 Level A | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | M-C1 at Day 3 pre-dose | 35.9 ng/mL | Standard Deviation 18.2 |
| Careseng 1370 Level A | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | PPD at Day 5 pre-dose | 22.2 ng/mL | Standard Deviation 22.3 |
| Careseng 1370 Level A | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | M-C1 at Day 5 12 hr post-dose | 139 ng/mL | Standard Deviation 69.4 |
| Careseng 1370 Level A | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | M-C1 at Day 4 pre-dose | 64.5 ng/mL | Standard Deviation 37.5 |
| Careseng 1370 Level A | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | PPD at Day 5 1 hr post-dose | 71.5 ng/mL | Standard Deviation 35.8 |
| Careseng 1370 Level A | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | M-C1 at Day 6 | 51.9 ng/mL | Standard Deviation 17.2 |
| Careseng 1370 Level A | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | PPD at Day 5 4 hr post-dose | 130 ng/mL | Standard Deviation 129 |
| Careseng 1370 Level A | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | M-C1 at Day 7 | 12.8 ng/mL | Standard Deviation 4.44 |
| Careseng 1370 Level A | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | PPD at Day 4 pre-dose | 19.8 ng/mL | Standard Deviation 13.3 |
| Careseng 1370 Level A | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | M-C1 at Day 8 | 3.58 ng/mL | Standard Deviation 2.46 |
| Careseng 1370 Level A | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | PPD at Day 5 0.5 hr post-dose | 65.8 ng/mL | Standard Deviation 31.6 |
| Careseng 1370 Level A | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | M-C2 at Day 2 pre-dose | 1.16 ng/mL | Standard Deviation 0.598 |
| Careseng 1370 Level A | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | PPD at Day 6 | 20.6 ng/mL | Standard Deviation 11.3 |
| Careseng 1370 Level A | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | M-C2 at Day 3 pre-dose | 1.01 ng/mL | Standard Deviation 0.785 |
| Careseng 1370 Level A | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | M-C2 at Day 5 1 hr post-dose | 21.6 ng/mL | Standard Deviation 8.92 |
| Careseng 1370 Level A | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | M-C2 at Day 4 pre-dose | 2.01 ng/mL | Standard Deviation 0.883 |
| Careseng 1370 Level A | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | M-C2 at Day 5 2 hr post-dose | 43.4 ng/mL | Standard Deviation 19 |
| Careseng 1370 Level A | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | PPD at Day 7 | 10.4 ng/mL | Standard Deviation 5.09 |
| Careseng 1370 Level A | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | M-C2 at Day 5 4 hr post-dose | 40.9 ng/mL | Standard Deviation 30.4 |
| Careseng 1370 Level A | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | PPD at Day 5 12 hr post-dose | 34.2 ng/mL | Standard Deviation 19.3 |
| Careseng 1370 Level A | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | M-C1 at Day 5 pre-dose | 46.9 ng/mL | Standard Deviation 34.6 |
| Careseng 1370 Level A | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | M-C2 at Day 5 12 hr post-dose | 6.24 ng/mL | Standard Deviation 3.72 |
| Careseng 1370 Level A | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | M-C2 at Day 5 pre-dose | 2.55 ng/mL | Standard Deviation 3.47 |
| Careseng 1370 Level A | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | M-C1 at Day 5 0.5 hr post-dose | 149 ng/mL | Standard Deviation 41.2 |
| Careseng 1370 Level A | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | M-C2 at Day 6 | 2.29 ng/mL | Standard Deviation 1.05 |
| Careseng 1370 Level A | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | PPD at Day 3 pre-dose | 11.3 ng/mL | Standard Deviation 5.7 |
| Careseng 1370 Level A | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | M-C2 at Day 7 | 0.188 ng/mL | Standard Deviation 0.459 |
| Careseng 1370 Level A | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | M-C1 at Day 5 1 hr post-dose | 187 ng/mL | Standard Deviation 48.1 |
| Careseng 1370 Level A | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | M-C2 at Day 8 | 0 ng/mL | Standard Deviation 0 |
| Careseng 1370 Level A | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | PPD at Day 2 pre-dose | 11.2 ng/mL | Standard Deviation 3.34 |
| Careseng 1370 Level B | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | M-C1 at Day 5 2 hr post-dose | 570 ng/mL | Standard Deviation 308 |
| Careseng 1370 Level B | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | M-C1 at Day 5 4 hr post-dose | 670 ng/mL | Standard Deviation 484 |
| Careseng 1370 Level B | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | M-C1 at Day 5 4.5 hr post-dose | 638 ng/mL | Standard Deviation 492 |
| Careseng 1370 Level B | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | M-C1 at Day 5 5 hr post-dose | 671 ng/mL | Standard Deviation 497 |
| Careseng 1370 Level B | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | M-C1 at Day 5 6 hr post-dose | 926 ng/mL | Standard Deviation 394 |
| Careseng 1370 Level B | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | M-C1 at Day 5 7 hr post-dose | 1040 ng/mL | Standard Deviation 411 |
| Careseng 1370 Level B | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | M-C1 at Day 5 10 hr post-dose | 816 ng/mL | Standard Deviation 515 |
| Careseng 1370 Level B | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | M-C1 at Day 5 12 hr post-dose | 673 ng/mL | Standard Deviation 508 |
| Careseng 1370 Level B | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | M-C1 at Day 5 16 hr post-dose | 411 ng/mL | Standard Deviation 372 |
| Careseng 1370 Level B | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | M-C1 at Day 6 | 247 ng/mL | Standard Deviation 295 |
| Careseng 1370 Level B | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | M-C1 at Day 7 | 59.3 ng/mL | Standard Deviation 86.8 |
| Careseng 1370 Level B | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | M-C1 at Day 8 | 14.1 ng/mL | Standard Deviation 18.7 |
| Careseng 1370 Level B | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | M-C2 at Day 2 pre-dose | 5.33 ng/mL | Standard Deviation 2.21 |
| Careseng 1370 Level B | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | M-C2 at Day 5 1 hr post-dose | 30.8 ng/mL | Standard Deviation 15.4 |
| Careseng 1370 Level B | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | M-C2 at Day 5 2 hr post-dose | 52.6 ng/mL | Standard Deviation 12.3 |
| Careseng 1370 Level B | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | M-C2 at Day 5 4 hr post-dose | 55.7 ng/mL | Standard Deviation 27.6 |
| Careseng 1370 Level B | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | M-C2 at Day 5 10 hr post-dose | 60.4 ng/mL | Standard Deviation 34.6 |
| Careseng 1370 Level B | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | M-C2 at Day 5 12 hr post-dose | 38.7 ng/mL | Standard Deviation 27.7 |
| Careseng 1370 Level B | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | M-C2 at Day 5 16 hr post-dose | 16.8 ng/mL | Standard Deviation 14.9 |
| Careseng 1370 Level B | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | M-C2 at Day 6 | 7.14 ng/mL | Standard Deviation 6.51 |
| Careseng 1370 Level B | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | M-C2 at Day 7 | 1.86 ng/mL | Standard Deviation 2.1 |
| Careseng 1370 Level B | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | M-C2 at Day 8 | 0.325 ng/mL | Standard Deviation 0.861 |
| Careseng 1370 Level B | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | PPD at Day 2 pre-dose | 42.9 ng/mL | Standard Deviation 6.15 |
| Careseng 1370 Level B | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | PPD at Day 3 pre-dose | 75.8 ng/mL | Standard Deviation 33.6 |
| Careseng 1370 Level B | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | PPD at Day 4 pre-dose | 63.0 ng/mL | Standard Deviation 41 |
| Careseng 1370 Level B | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | PPD at Day 5 pre-dose | 57.1 ng/mL | Standard Deviation 42.4 |
| Careseng 1370 Level B | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | PPD at Day 5 0.5 hr post-dose | 121 ng/mL | Standard Deviation 68.7 |
| Careseng 1370 Level B | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | PPD at Day 5 2 hr post-dose | 248 ng/mL | Standard Deviation 94 |
| Careseng 1370 Level B | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | PPD at Day 5 4 hr post-dose | 205 ng/mL | Standard Deviation 116 |
| Careseng 1370 Level B | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | PPD at Day 5 4.5 hr post-dose | 209 ng/mL | Standard Deviation 120 |
| Careseng 1370 Level B | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | PPD at Day 5 5 hr post-dose | 257 ng/mL | Standard Deviation 117 |
| Careseng 1370 Level B | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | PPD at Day 5 6 hr post-dose | 488 ng/mL | Standard Deviation 149 |
| Careseng 1370 Level B | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | PPD at Day 5 7 hr post-dose | 485 ng/mL | Standard Deviation 224 |
| Careseng 1370 Level B | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | PPD at Day 5 8 hr post-dose | 365 ng/mL | Standard Deviation 241 |
| Careseng 1370 Level B | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | PPD at Day 5 9 hr post-dose | 319 ng/mL | Standard Deviation 222 |
| Careseng 1370 Level B | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | PPD at Day 5 10 hr post-dose | 253 ng/mL | Standard Deviation 186 |
| Careseng 1370 Level B | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | PPD at Day 7 | 32.0 ng/mL | Standard Deviation 19.1 |
| Careseng 1370 Level B | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | PPD at Day 8 | 17.5 ng/mL | Standard Deviation 10.3 |
| Careseng 1370 Level B | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | M-C1 at Day 2 pre-dose | 173 ng/mL | Standard Deviation 85.6 |
| Careseng 1370 Level B | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | M-C1 at Day 3 pre-dose | 301 ng/mL | Standard Deviation 275 |
| Careseng 1370 Level B | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | M-C1 at Day 5 8 hr post-dose | 934 ng/mL | Standard Deviation 487 |
| Careseng 1370 Level B | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | M-C1 at Day 5 9 hr post-dose | 925 ng/mL | Standard Deviation 567 |
| Careseng 1370 Level B | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | M-C2 at Day 3 pre-dose | 12.2 ng/mL | Standard Deviation 12.8 |
| Careseng 1370 Level B | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | M-C2 at Day 4 pre-dose | 7.44 ng/mL | Standard Deviation 6.87 |
| Careseng 1370 Level B | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | M-C2 at Day 5 pre-dose | 6.07 ng/mL | Standard Deviation 6.06 |
| Careseng 1370 Level B | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | M-C2 at Day 5 0.5 hr post-dose | 17.4 ng/mL | Standard Deviation 10.4 |
| Careseng 1370 Level B | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | M-C2 at Day 5 4.5 hr post-dose | 52.5 ng/mL | Standard Deviation 32.9 |
| Careseng 1370 Level B | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | M-C2 at Day 5 5 hr post-dose | 57.4 ng/mL | Standard Deviation 32.2 |
| Careseng 1370 Level B | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | M-C2 at Day 5 6 hr post-dose | 89.8 ng/mL | Standard Deviation 25.4 |
| Careseng 1370 Level B | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | M-C2 at Day 5 7 hr post-dose | 105 ng/mL | Standard Deviation 34.2 |
| Careseng 1370 Level B | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | M-C2 at Day 5 8 hr post-dose | 87.1 ng/mL | Standard Deviation 38 |
| Careseng 1370 Level B | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | M-C2 at Day 5 9 hr post-dose | 75.3 ng/mL | Standard Deviation 38.3 |
| Careseng 1370 Level B | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | PPD at Day 5 1 hr post-dose | 146 ng/mL | Standard Deviation 78.4 |
| Careseng 1370 Level B | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | PPD at Day 5 12 hr post-dose | 184 ng/mL | Standard Deviation 137 |
| Careseng 1370 Level B | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | PPD at Day 5 16 hr post-dose | 107 ng/mL | Standard Deviation 74.4 |
| Careseng 1370 Level B | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | PPD at Day 6 | 71.1 ng/mL | Standard Deviation 40.7 |
| Careseng 1370 Level B | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | M-C1 at Day 4 pre-dose | 187 ng/mL | Standard Deviation 192 |
| Careseng 1370 Level B | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | M-C1 at Day 5 pre-dose | 215 ng/mL | Standard Deviation 285 |
| Careseng 1370 Level B | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | M-C1 at Day 5 0.5 hr post-dose | 296 ng/mL | Standard Deviation 274 |
| Careseng 1370 Level B | Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites | M-C1 at Day 5 1 hr post-dose | 390 ng/mL | Standard Deviation 334 |
Secondary
Significantly Abnormal PR, QRS, QT, QTc Intervals Compared to Baseline
PR, QRS, QT and QTc intervals were measured by EKG.
Time frame: Day -14 to Day 22
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Careseng 1370 Level A | Significantly Abnormal PR, QRS, QT, QTc Intervals Compared to Baseline | PR Interval (msec) (Day 2, Pre-dose - Baseline) | -2.00 msec | Standard Deviation 7.403 |
| Careseng 1370 Level A | Significantly Abnormal PR, QRS, QT, QTc Intervals Compared to Baseline | QT Interval (msec) (Day 12 - Baseline) | -23.50 msec | Standard Deviation 18.229 |
| Careseng 1370 Level A | Significantly Abnormal PR, QRS, QT, QTc Intervals Compared to Baseline | QRS Interval (msec) (Day 12 - Baseline) | -2.17 msec | Standard Deviation 5.037 |
| Careseng 1370 Level A | Significantly Abnormal PR, QRS, QT, QTc Intervals Compared to Baseline | PR Interval (msec) (Day 5, Pre-dose - Baseline) | 3.67 msec | Standard Deviation 6.623 |
| Careseng 1370 Level A | Significantly Abnormal PR, QRS, QT, QTc Intervals Compared to Baseline | QT Interval (msec) (Day 1, 8 hours post dosing - Baseline) | -21 msec | Standard Deviation 23.673 |
| Careseng 1370 Level A | Significantly Abnormal PR, QRS, QT, QTc Intervals Compared to Baseline | QTc Interval (msec) (Day 1, 4 hours post dosing - Baseline) | 1.83 msec | Standard Deviation 12.576 |
| Careseng 1370 Level A | Significantly Abnormal PR, QRS, QT, QTc Intervals Compared to Baseline | QTc Interval (msec) (Day 1, 12 hours post dosing - Baseline) | 7.83 msec | Standard Deviation 5.947 |
| Careseng 1370 Level A | Significantly Abnormal PR, QRS, QT, QTc Intervals Compared to Baseline | PR Interval (msec) (Day 1, 4 hours post dosing - Baseline) | 0.00 msec | Standard Deviation 10.863 |
| Careseng 1370 Level A | Significantly Abnormal PR, QRS, QT, QTc Intervals Compared to Baseline | QTc Interval (msec) (Day 3, Pre-dose - Baseline) | 6.00 msec | Standard Deviation 13.914 |
| Careseng 1370 Level A | Significantly Abnormal PR, QRS, QT, QTc Intervals Compared to Baseline | QT Interval (msec) (Day 5, 12 hours post dosing - Baseline) | -25.67 msec | Standard Deviation 13.171 |
| Careseng 1370 Level A | Significantly Abnormal PR, QRS, QT, QTc Intervals Compared to Baseline | QTc Interval (msec) (Day 4, Pre-dose - Baseline) | 13.33 msec | Standard Deviation 11.759 |
| Careseng 1370 Level A | Significantly Abnormal PR, QRS, QT, QTc Intervals Compared to Baseline | PR Interval (msec) (Day 1, 12 hours post dosing - Baseline) | -5.17 msec | Standard Deviation 3.43 |
| Careseng 1370 Level A | Significantly Abnormal PR, QRS, QT, QTc Intervals Compared to Baseline | QTc Interval (msec) (Day 6 - Baseline) | 8.50 msec | Standard Deviation 14.923 |
| Careseng 1370 Level A | Significantly Abnormal PR, QRS, QT, QTc Intervals Compared to Baseline | PR Interval (msec) (Day 5, 4 hours post dosing - Baseline) | 2.67 msec | Standard Deviation 7.09 |
| Careseng 1370 Level B | Significantly Abnormal PR, QRS, QT, QTc Intervals Compared to Baseline | QTc Interval (msec) (Day 6 - Baseline) | 8.71 msec | Standard Deviation 8.693 |
| Careseng 1370 Level B | Significantly Abnormal PR, QRS, QT, QTc Intervals Compared to Baseline | PR Interval (msec) (Day 5, Pre-dose - Baseline) | -16.57 msec | Standard Deviation 14.547 |
| Careseng 1370 Level B | Significantly Abnormal PR, QRS, QT, QTc Intervals Compared to Baseline | QT Interval (msec) (Day 1, 8 hours post dosing - Baseline) | -9.71 msec | Standard Deviation 23.655 |
| Careseng 1370 Level B | Significantly Abnormal PR, QRS, QT, QTc Intervals Compared to Baseline | QT Interval (msec) (Day 5, 12 hours post dosing - Baseline) | -7.86 msec | Standard Deviation 40.544 |
| Careseng 1370 Level B | Significantly Abnormal PR, QRS, QT, QTc Intervals Compared to Baseline | QT Interval (msec) (Day 12 - Baseline) | -17.43 msec | Standard Deviation 25.999 |
| Careseng 1370 Level B | Significantly Abnormal PR, QRS, QT, QTc Intervals Compared to Baseline | PR Interval (msec) (Day 1, 4 hours post dosing - Baseline) | -16.57 msec | Standard Deviation 25.045 |
| Careseng 1370 Level B | Significantly Abnormal PR, QRS, QT, QTc Intervals Compared to Baseline | PR Interval (msec) (Day 1, 12 hours post dosing - Baseline) | -10.00 msec | Standard Deviation 19.545 |
| Careseng 1370 Level B | Significantly Abnormal PR, QRS, QT, QTc Intervals Compared to Baseline | PR Interval (msec) (Day 5, 4 hours post dosing - Baseline) | -16.14 msec | Standard Deviation 13.582 |
| Careseng 1370 Level B | Significantly Abnormal PR, QRS, QT, QTc Intervals Compared to Baseline | QRS Interval (msec) (Day 12 - Baseline) | -4.29 msec | Standard Deviation 3.684 |
| Careseng 1370 Level B | Significantly Abnormal PR, QRS, QT, QTc Intervals Compared to Baseline | QTc Interval (msec) (Day 1, 4 hours post dosing - Baseline) | 16.71 msec | Standard Deviation 13.937 |
| Careseng 1370 Level B | Significantly Abnormal PR, QRS, QT, QTc Intervals Compared to Baseline | QTc Interval (msec) (Day 1, 12 hours post dosing - Baseline) | 16.57 msec | Standard Deviation 28.213 |
| Careseng 1370 Level B | Significantly Abnormal PR, QRS, QT, QTc Intervals Compared to Baseline | QTc Interval (msec) (Day 3, Pre-dose - Baseline) | 15.57 msec | Standard Deviation 13.563 |
| Careseng 1370 Level B | Significantly Abnormal PR, QRS, QT, QTc Intervals Compared to Baseline | QTc Interval (msec) (Day 4, Pre-dose - Baseline) | 7.29 msec | Standard Deviation 19.44 |
| Careseng 1370 Level B | Significantly Abnormal PR, QRS, QT, QTc Intervals Compared to Baseline | PR Interval (msec) (Day 2, Pre-dose - Baseline) | -12.57 msec | Standard Deviation 3.823 |
Secondary
Significantly Abnormal Ventricular Rate Compared to Baseline
Ventricular rate was measured by EKG.
Time frame: Day -14 to Day 22
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Careseng 1370 Level A | Significantly Abnormal Ventricular Rate Compared to Baseline | Day 1, 4 hours post dosing - Baseline | 6.50 beats/min | Standard Deviation 12.755 |
| Careseng 1370 Level A | Significantly Abnormal Ventricular Rate Compared to Baseline | Day 5, 1 hour post dosing - Baseline | -1.00 beats/min | Standard Deviation 4.382 |
| Careseng 1370 Level A | Significantly Abnormal Ventricular Rate Compared to Baseline | Day 5, 4 hours post dosing - Baseline | 6.33 beats/min | Standard Deviation 6.022 |
| Careseng 1370 Level A | Significantly Abnormal Ventricular Rate Compared to Baseline | Day 5, 8 hours post dosing - Baseline | 10.00 beats/min | Standard Deviation 8.367 |
| Careseng 1370 Level A | Significantly Abnormal Ventricular Rate Compared to Baseline | Day 5, 12 hours post dosing - Baseline | 10.67 beats/min | Standard Deviation 8.091 |
| Careseng 1370 Level A | Significantly Abnormal Ventricular Rate Compared to Baseline | Day 12 - Baseline | 11.50 beats/min | Standard Deviation 9.375 |
| Careseng 1370 Level B | Significantly Abnormal Ventricular Rate Compared to Baseline | Day 5, 12 hours post dosing - Baseline | 5.86 beats/min | Standard Deviation 11.276 |
| Careseng 1370 Level B | Significantly Abnormal Ventricular Rate Compared to Baseline | Day 1, 4 hours post dosing - Baseline | 9.29 beats/min | Standard Deviation 9.861 |
| Careseng 1370 Level B | Significantly Abnormal Ventricular Rate Compared to Baseline | Day 5, 8 hours post dosing - Baseline | 6.00 beats/min | Standard Deviation 9.147 |
| Careseng 1370 Level B | Significantly Abnormal Ventricular Rate Compared to Baseline | Day 5, 1 hour post dosing - Baseline | 7.57 beats/min | Standard Deviation 5.35 |
| Careseng 1370 Level B | Significantly Abnormal Ventricular Rate Compared to Baseline | Day 12 - Baseline | 10.29 beats/min | Standard Deviation 7.952 |
| Careseng 1370 Level B | Significantly Abnormal Ventricular Rate Compared to Baseline | Day 5, 4 hours post dosing - Baseline | 4.57 beats/min | Standard Deviation 10.581 |
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
Time frame: Day -14 to Day 22
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Careseng 1370 Level A | Number of Participants With Abnormal Immune Profile | CD3+/CD8+ (%) | 0 Participants |
| Careseng 1370 Level A | Number of Participants With Abnormal Immune Profile | CD3+ (%) | 0 Participants |
| Careseng 1370 Level A | Number of Participants With Abnormal Immune Profile | CD3+/CD4+ (%) | 0 Participants |
| Careseng 1370 Level A | Number of Participants With Abnormal Immune Profile | CD19+ (%) | 0 Participants |
| Careseng 1370 Level A | Number of Participants With Abnormal Immune Profile | D16+/CD56+ (%) | 0 Participants |
| Careseng 1370 Level A | Number of Participants With Abnormal Immune Profile | CD4/CD8 Ratio | 0 Participants |
| Careseng 1370 Level B | Number of Participants With Abnormal Immune Profile | D16+/CD56+ (%) | 0 Participants |
| Careseng 1370 Level B | Number of Participants With Abnormal Immune Profile | CD19+ (%) | 0 Participants |
| Careseng 1370 Level B | Number of Participants With Abnormal Immune Profile | CD3+ (%) | 0 Participants |
| Careseng 1370 Level B | Number of Participants With Abnormal Immune Profile | CD4/CD8 Ratio | 0 Participants |
| Careseng 1370 Level B | Number of Participants With Abnormal Immune Profile | CD3+/CD4+ (%) | 0 Participants |
| Careseng 1370 Level B | Number of Participants With Abnormal Immune Profile | CD3+/CD8+ (%) | 0 Participants |