Trial Outcomes & Findings for Careseng 1370 for Healthy Volunteers (NCT NCT03974516)
NCT ID: NCT03974516
Last Updated: 2024-11-22
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
13 participants
Primary outcome timeframe
Day -14 to Day 22
Results posted on
2024-11-22
Participant Flow
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.
Participant milestones
| Measure |
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)
|
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)
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
7
|
|
Overall Study
COMPLETED
|
6
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Careseng 1370 for Healthy Volunteers
Baseline characteristics by cohort
| Measure |
Careseng 1370 Level A
n=6 Participants
Level A (1 sachet): 1 sachet before breakfast;
Careseng 1370: Careseng 1370 should be taken around 1 hour before meal.
|
Careseng 1370 Level B
n=7 Participants
Level B (2 sachets): 1 sachet before breakfast, 1 sachet before lunch
Careseng 1370: Careseng 1370 should be taken around 1 hour before meal.
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
24.3 years
STANDARD_DEVIATION 2.25 • n=39 Participants
|
26.0 years
STANDARD_DEVIATION 2.52 • n=41 Participants
|
25.2 years
STANDARD_DEVIATION 2.45 • n=35 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
6 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=39 Participants
|
7 Participants
n=41 Participants
|
13 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Region of Enrollment
Taiwan
|
6 participants
n=39 Participants
|
7 participants
n=41 Participants
|
13 participants
n=35 Participants
|
|
Body Weight
|
62.3 kg
STANDARD_DEVIATION 11.59 • n=39 Participants
|
55.9 kg
STANDARD_DEVIATION 8.31 • n=41 Participants
|
58.9 kg
STANDARD_DEVIATION 10.07 • n=35 Participants
|
|
Height
|
167.3 cm
STANDARD_DEVIATION 9.81 • n=39 Participants
|
162.4 cm
STANDARD_DEVIATION 7.23 • n=41 Participants
|
164.7 cm
STANDARD_DEVIATION 8.52 • n=35 Participants
|
|
BMI
|
22.11 kg/m^2
STANDARD_DEVIATION 1.572 • n=39 Participants
|
20.90 kg/m^2
STANDARD_DEVIATION 2.002 • n=41 Participants
|
21.46 kg/m^2
STANDARD_DEVIATION 1.851 • n=35 Participants
|
PRIMARY outcome
Timeframe: Day -14 to Day 22Population: Volunteers received any Careseng 1370
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.
Outcome measures
| Measure |
Careseng 1370 Level A
n=6 Participants
Level A (1 sachet): 1 sachet before breakfast;
Careseng 1370: Careseng 1370 should be taken around 1 hour before meal.
|
Careseng 1370 Level B
n=7 Participants
Level B (2 sachets): 1 sachet before breakfast, 1 sachet before lunch
Careseng 1370: Careseng 1370 should be taken around 1 hour before meal.
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs) and/or Serious Adverse Events (SAEs)
Subjects with AE
|
3 Participants
|
5 Participants
|
|
Number of Participants With Adverse Events (AEs) and/or Serious Adverse Events (SAEs)
Subjects with SAE
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day -14 to Day 22Population: 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.
\*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.
Outcome measures
| Measure |
Careseng 1370 Level A
n=6 Participants
Level A (1 sachet): 1 sachet before breakfast;
Careseng 1370: Careseng 1370 should be taken around 1 hour before meal.
|
Careseng 1370 Level B
n=7 Participants
Level B (2 sachets): 1 sachet before breakfast, 1 sachet before lunch
Careseng 1370: Careseng 1370 should be taken around 1 hour before meal.
|
|---|---|---|
|
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
|
7 Participants
|
|
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
|
7 Participants
|
|
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
|
7 Participants
|
|
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
|
7 Participants
|
|
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
|
7 Participants
|
|
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
|
7 Participants
|
|
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
|
7 Participants
|
SECONDARY outcome
Timeframe: Day -14 to Day 22Population: 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.
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.
Outcome measures
| Measure |
Careseng 1370 Level A
n=6 Participants
Level A (1 sachet): 1 sachet before breakfast;
Careseng 1370: Careseng 1370 should be taken around 1 hour before meal.
|
Careseng 1370 Level B
n=7 Participants
Level B (2 sachets): 1 sachet before breakfast, 1 sachet before lunch
Careseng 1370: Careseng 1370 should be taken around 1 hour before meal.
|
|---|---|---|
|
Number of Participants With Clinical Laboratory Abnormalities
APTT (Day 6), Clinically Significant Abnormalities
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities
Lymphocytes (%) (Day 2), Clinically Significant Abnormalities
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities
Lymphocytes (%) (Day 12), Clinically Significant Abnormalities
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities
Lymphocyte Count (10^9/L) (Day 2), Clinically Significant Abnormalities
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities
Lymphocyte Count (10^9/L) (Day 12), Clinically Significant Abnormalities
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities
International normalized ratio (Day5, 4 hours post dosing), Clinically Significant Abnormalities
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities
APTT (Day 1, 8 hours post dosing), Clinically Significant Abnormalities
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities
APTT (Day 2), Clinically Significant Abnormalities
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities
APTT (Day 3), Clinically Significant Abnormalities
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities
APTT (Day 4), Clinically Significant Abnormalities
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities
APTT (Day 5, Pre-dose), Clinically Significant Abnormalities
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities
APTT (Day 5, 4 hours post dosing), Clinically Significant Abnormalities
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities
APTT (Day 22), Clinically Significant Abnormalities
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities
Lipase (U/L) (Day 1, 8 hours post dosing), Clinically Significant Abnormalities
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities
Lipase (U/L) (Day 3), Clinically Significant Abnormalities
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities
Lipase (U/L) (Day 6), Clinically Significant Abnormalities
|
0 Participants
|
2 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities
Lipase (U/L) (Day 22), Clinically Significant Abnormalities
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day -14 to Day 22Population: 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.
Vital signs measurement will consist of systolic/diastolic blood pressure, respiratory rate, pulse rate or heart rate, and body temperature.
Outcome measures
| Measure |
Careseng 1370 Level A
n=6 Participants
Level A (1 sachet): 1 sachet before breakfast;
Careseng 1370: Careseng 1370 should be taken around 1 hour before meal.
|
Careseng 1370 Level B
n=7 Participants
Level B (2 sachets): 1 sachet before breakfast, 1 sachet before lunch
Careseng 1370: Careseng 1370 should be taken around 1 hour before meal.
|
|---|---|---|
|
Number of Participants With Vital Signs Abnormalities
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day -14 to Day 22Population: 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.
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.
Outcome measures
| Measure |
Careseng 1370 Level A
n=6 Participants
Level A (1 sachet): 1 sachet before breakfast;
Careseng 1370: Careseng 1370 should be taken around 1 hour before meal.
|
Careseng 1370 Level B
n=7 Participants
Level B (2 sachets): 1 sachet before breakfast, 1 sachet before lunch
Careseng 1370: Careseng 1370 should be taken around 1 hour before meal.
|
|---|---|---|
|
Number of Participants With Physical Examination Abnormalities
Extremities (Day 12)
|
0 Participants
|
1 Participants
|
|
Number of Participants With Physical Examination Abnormalities
Skin (Day 22)
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 2 to Day 8Population: 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.
Maximum plasma concentration (Cmax) of PPD and its metabolites, M-C1, and M-C2.
Outcome measures
| Measure |
Careseng 1370 Level A
n=6 Participants
Level A (1 sachet): 1 sachet before breakfast;
Careseng 1370: Careseng 1370 should be taken around 1 hour before meal.
|
Careseng 1370 Level B
n=7 Participants
Level B (2 sachets): 1 sachet before breakfast, 1 sachet before lunch
Careseng 1370: Careseng 1370 should be taken around 1 hour before meal.
|
|---|---|---|
|
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
|
42.9 ng/mL
Standard Deviation 6.15
|
|
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 5.70
|
75.8 ng/mL
Standard Deviation 33.6
|
|
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
|
63.0 ng/mL
Standard Deviation 41.0
|
|
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
|
57.1 ng/mL
Standard Deviation 42.4
|
|
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
|
121 ng/mL
Standard Deviation 68.7
|
|
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
|
146 ng/mL
Standard Deviation 78.4
|
|
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 73.0
|
248 ng/mL
Standard Deviation 94.0
|
|
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
|
205 ng/mL
Standard Deviation 116
|
|
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
|
|
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
|
|
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
|
488 ng/mL
Standard Deviation 149
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
184 ng/mL
Standard Deviation 137
|
|
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
|
|
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
|
71.1 ng/mL
Standard Deviation 40.7
|
|
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
|
32.0 ng/mL
Standard Deviation 19.1
|
|
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
|
17.5 ng/mL
Standard Deviation 10.3
|
|
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
|
173 ng/mL
Standard Deviation 85.6
|
|
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
|
301 ng/mL
Standard Deviation 275
|
|
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
|
187 ng/mL
Standard Deviation 192
|
|
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
|
215 ng/mL
Standard Deviation 285
|
|
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
|
296 ng/mL
Standard Deviation 274
|
|
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
|
390 ng/mL
Standard Deviation 334
|
|
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
|
570 ng/mL
Standard Deviation 308
|
|
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
|
670 ng/mL
Standard Deviation 484
|
|
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
|
|
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
|
|
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
|
926 ng/mL
Standard Deviation 394
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
673 ng/mL
Standard Deviation 508
|
|
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
|
|
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
|
247 ng/mL
Standard Deviation 295
|
|
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
|
59.3 ng/mL
Standard Deviation 86.8
|
|
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
|
14.1 ng/mL
Standard Deviation 18.7
|
|
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
|
5.33 ng/mL
Standard Deviation 2.21
|
|
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
|
12.2 ng/mL
Standard Deviation 12.8
|
|
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
|
7.44 ng/mL
Standard Deviation 6.87
|
|
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
|
6.07 ng/mL
Standard Deviation 6.06
|
|
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
|
17.4 ng/mL
Standard Deviation 10.4
|
|
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
|
30.8 ng/mL
Standard Deviation 15.4
|
|
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 19.0
|
52.6 ng/mL
Standard Deviation 12.3
|
|
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
|
55.7 ng/mL
Standard Deviation 27.6
|
|
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
|
|
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
|
|
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
|
89.8 ng/mL
Standard Deviation 25.4
|
|
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
|
|
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 38.0
|
|
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
|
|
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
|
|
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
|
38.7 ng/mL
Standard Deviation 27.7
|
|
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
|
|
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
|
7.14 ng/mL
Standard Deviation 6.51
|
|
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
|
1.86 ng/mL
Standard Deviation 2.10
|
|
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
|
0.325 ng/mL
Standard Deviation 0.861
|
SECONDARY outcome
Timeframe: Day -14 to Day 22Population: 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.
Sinus rhythm was measured by 12-lead EKG
Outcome measures
| Measure |
Careseng 1370 Level A
n=6 Participants
Level A (1 sachet): 1 sachet before breakfast;
Careseng 1370: Careseng 1370 should be taken around 1 hour before meal.
|
Careseng 1370 Level B
n=7 Participants
Level B (2 sachets): 1 sachet before breakfast, 1 sachet before lunch
Careseng 1370: Careseng 1370 should be taken around 1 hour before meal.
|
|---|---|---|
|
Participants With Abnormal Sinus Rhythm
Baseline
|
6 Participants
|
0 Participants
|
|
Participants With Abnormal Sinus Rhythm
Day 1, 1 hour post dosing
|
3 Participants
|
0 Participants
|
|
Participants With Abnormal Sinus Rhythm
Day 1, 4 hour post dosing
|
3 Participants
|
0 Participants
|
|
Participants With Abnormal Sinus Rhythm
Day 1, 8 hour post dosing
|
1 Participants
|
0 Participants
|
|
Participants With Abnormal Sinus Rhythm
Day 1, 12 hour post dosing
|
1 Participants
|
0 Participants
|
|
Participants With Abnormal Sinus Rhythm
Day 2, pre-dose
|
2 Participants
|
0 Participants
|
|
Participants With Abnormal Sinus Rhythm
Day 2, 1 hour post dosing
|
1 Participants
|
0 Participants
|
|
Participants With Abnormal Sinus Rhythm
Day 3, pre-dose
|
2 Participants
|
0 Participants
|
|
Participants With Abnormal Sinus Rhythm
Day 3, 1 hour post dosing
|
2 Participants
|
0 Participants
|
|
Participants With Abnormal Sinus Rhythm
Day 4, pre-dose
|
1 Participants
|
0 Participants
|
|
Participants With Abnormal Sinus Rhythm
Day 4, 1 hour post dosing
|
1 Participants
|
0 Participants
|
|
Participants With Abnormal Sinus Rhythm
Day 5, pre-dose
|
4 Participants
|
0 Participants
|
|
Participants With Abnormal Sinus Rhythm
Day 5, 1 hour post dosing
|
4 Participants
|
0 Participants
|
|
Participants With Abnormal Sinus Rhythm
Day 5, 4 hours post dosing
|
2 Participants
|
0 Participants
|
|
Participants With Abnormal Sinus Rhythm
Day 5, 8 hours post dosing
|
1 Participants
|
0 Participants
|
|
Participants With Abnormal Sinus Rhythm
Day 5, 12 hours post dosing
|
1 Participants
|
0 Participants
|
|
Participants With Abnormal Sinus Rhythm
Day 6
|
0 Participants
|
0 Participants
|
|
Participants With Abnormal Sinus Rhythm
Day 12
|
0 Participants
|
0 Participants
|
|
Participants With Abnormal Sinus Rhythm
Day 22
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day -14 to Day 22Population: 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.
Ventricular rate was measured by EKG.
Outcome measures
| Measure |
Careseng 1370 Level A
n=6 Participants
Level A (1 sachet): 1 sachet before breakfast;
Careseng 1370: Careseng 1370 should be taken around 1 hour before meal.
|
Careseng 1370 Level B
n=7 Participants
Level B (2 sachets): 1 sachet before breakfast, 1 sachet before lunch
Careseng 1370: Careseng 1370 should be taken around 1 hour before meal.
|
|---|---|---|
|
Significantly Abnormal Ventricular Rate Compared to Baseline
Day 1, 4 hours post dosing - Baseline
|
6.50 beats/min
Standard Deviation 12.755
|
9.29 beats/min
Standard Deviation 9.861
|
|
Significantly Abnormal Ventricular Rate Compared to Baseline
Day 5, 1 hour post dosing - Baseline
|
-1.00 beats/min
Standard Deviation 4.382
|
7.57 beats/min
Standard Deviation 5.350
|
|
Significantly Abnormal Ventricular Rate Compared to Baseline
Day 5, 4 hours post dosing - Baseline
|
6.33 beats/min
Standard Deviation 6.022
|
4.57 beats/min
Standard Deviation 10.581
|
|
Significantly Abnormal Ventricular Rate Compared to Baseline
Day 5, 8 hours post dosing - Baseline
|
10.00 beats/min
Standard Deviation 8.367
|
6.00 beats/min
Standard Deviation 9.147
|
|
Significantly Abnormal Ventricular Rate Compared to Baseline
Day 5, 12 hours post dosing - Baseline
|
10.67 beats/min
Standard Deviation 8.091
|
5.86 beats/min
Standard Deviation 11.276
|
|
Significantly Abnormal Ventricular Rate Compared to Baseline
Day 12 - Baseline
|
11.50 beats/min
Standard Deviation 9.375
|
10.29 beats/min
Standard Deviation 7.952
|
SECONDARY outcome
Timeframe: Day -14 to Day 22Population: 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.
PR, QRS, QT and QTc intervals were measured by EKG.
Outcome measures
| Measure |
Careseng 1370 Level A
n=6 Participants
Level A (1 sachet): 1 sachet before breakfast;
Careseng 1370: Careseng 1370 should be taken around 1 hour before meal.
|
Careseng 1370 Level B
n=7 Participants
Level B (2 sachets): 1 sachet before breakfast, 1 sachet before lunch
Careseng 1370: Careseng 1370 should be taken around 1 hour before meal.
|
|---|---|---|
|
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
|
-16.57 msec
Standard Deviation 25.045
|
|
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 3.430
|
-10.00 msec
Standard Deviation 19.545
|
|
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
|
-12.57 msec
Standard Deviation 3.823
|
|
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
|
-16.57 msec
Standard Deviation 14.547
|
|
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 7.090
|
-16.14 msec
Standard Deviation 13.582
|
|
Significantly Abnormal PR, QRS, QT, QTc Intervals Compared to Baseline
QRS Interval (msec) (Day 12 - Baseline)
|
-2.17 msec
Standard Deviation 5.037
|
-4.29 msec
Standard Deviation 3.684
|
|
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
|
-9.71 msec
Standard Deviation 23.655
|
|
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
|
-7.86 msec
Standard Deviation 40.544
|
|
Significantly Abnormal PR, QRS, QT, QTc Intervals Compared to Baseline
QT Interval (msec) (Day 12 - Baseline)
|
-23.50 msec
Standard Deviation 18.229
|
-17.43 msec
Standard Deviation 25.999
|
|
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
|
16.71 msec
Standard Deviation 13.937
|
|
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
|
16.57 msec
Standard Deviation 28.213
|
|
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
|
15.57 msec
Standard Deviation 13.563
|
|
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
|
7.29 msec
Standard Deviation 19.440
|
|
Significantly Abnormal PR, QRS, QT, QTc Intervals Compared to Baseline
QTc Interval (msec) (Day 6 - Baseline)
|
8.50 msec
Standard Deviation 14.923
|
8.71 msec
Standard Deviation 8.693
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day -14 to Day 22Population: 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.
Immune profile includes percentages of CD3+, CD3+/CD4+, CD3+/CD8+, CD19+, CD16+/CD56+, and CD4/CD8 ratio
Outcome measures
| Measure |
Careseng 1370 Level A
n=6 Participants
Level A (1 sachet): 1 sachet before breakfast;
Careseng 1370: Careseng 1370 should be taken around 1 hour before meal.
|
Careseng 1370 Level B
n=7 Participants
Level B (2 sachets): 1 sachet before breakfast, 1 sachet before lunch
Careseng 1370: Careseng 1370 should be taken around 1 hour before meal.
|
|---|---|---|
|
Number of Participants With Abnormal Immune Profile
CD3+ (%)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Immune Profile
CD3+/CD4+ (%)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Immune Profile
CD3+/CD8+ (%)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Immune Profile
CD19+ (%)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Immune Profile
D16+/CD56+ (%)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Immune Profile
CD4/CD8 Ratio
|
0 Participants
|
0 Participants
|
Adverse Events
Careseng 1370 Level A
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Careseng 1370 Level B
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Careseng 1370 Level A
n=6 participants at risk
Level A (1 sachet): 1 sachet before breakfast
Careseng 1370: Careseng 1370 should be taken around 1 hour before meal.
|
Careseng 1370 Level B
n=7 participants at risk
Level B (2 sachets): 1 sachet before breakfast, 1 sachet before lunch
Careseng 1370: Careseng 1370 should be taken around 1 hour before meal.
|
|---|---|---|
|
Investigations
Lipase increased
|
0.00%
0/6 • Day -14 to Day 22
|
42.9%
3/7 • Number of events 5 • Day -14 to Day 22
|
|
Investigations
Activated partial thromboplastin time prolonged
|
33.3%
2/6 • Number of events 3 • Day -14 to Day 22
|
0.00%
0/7 • Day -14 to Day 22
|
|
Investigations
Lymphocyte count decreased
|
16.7%
1/6 • Number of events 1 • Day -14 to Day 22
|
14.3%
1/7 • Number of events 1 • Day -14 to Day 22
|
|
Investigations
Prothrombin time prolonged
|
16.7%
1/6 • Number of events 1 • Day -14 to Day 22
|
0.00%
0/7 • Day -14 to Day 22
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/6 • Day -14 to Day 22
|
14.3%
1/7 • Number of events 1 • Day -14 to Day 22
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/6 • Day -14 to Day 22
|
14.3%
1/7 • Number of events 1 • Day -14 to Day 22
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60