This study will be performed in healthy volunteers in a conventional 3+3 dose-escalation design.
Four cohorts (dose level A, B, C, and D) of up to 6 evaluable volunteers per cohort are planned to be sequentially accrued to receive Careseng 1370 1, 2, and 3 sachets per day, 4,000 mg/sachet before meal (starting from 1 sachet). At least 5 days of staggering and with the investigator's judgement of no safety concern will be required to administer the next volunteer for the first three volunteers of each cohort. The staggering time is counted from Day 1 of one volunteer to Day 1 of the next volunteer. Careseng 1370 should be taken around 1 hour before meal. No volunteer is allowed to be assigned to more than 1 dose level. All dose escalation/de-escalation decisions will be made by the Data and Safety Monitoring Board (DSMB).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
13
Careseng 1370 should be taken around 1 hour before meal.
Taipei Medical University Hospital
Taipei, Taiwan
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
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
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
Number of Participants With Vital Signs Abnormalities
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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
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
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
Participants With Abnormal Sinus Rhythm
Sinus rhythm was measured by 12-lead EKG
Time frame: Day -14 to Day 22
Significantly Abnormal Ventricular Rate Compared to Baseline
Ventricular rate was measured by EKG.
Time frame: Day -14 to Day 22
Significantly Abnormal PR, QRS, QT, QTc Intervals Compared to Baseline
PR, QRS, QT and QTc intervals were measured by EKG.
Time frame: Day -14 to Day 22