Careseng 1370 for Healthy Volunteers
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|ClinicalTrials.gov Identifier: NCT03974516|
Recruitment Status : Not yet recruiting
First Posted : June 5, 2019
Last Update Posted : June 5, 2019
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, 3 and 4 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).
|Condition or disease||Intervention/treatment||Phase|
|Chemotherapy-induced Myelosuppression||Drug: Careseng 1370||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Dose-Escalation Study in Healthy Volunteers to Evaluate the Safety and Tolerability Profiles of Careseng 1370|
|Estimated Study Start Date :||May 1, 2020|
|Estimated Primary Completion Date :||December 30, 2021|
|Estimated Study Completion Date :||June 30, 2022|
Experimental: Careseng 1370
Four dose cohorts are employed for Careseng 1370 oral administration in healthy volunteers:
Drug: Careseng 1370
Careseng 1370 should be taken around 1 hour before meal.
- Incidence of adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Day -14 to Day 22 ]
- Changes from baseline to applicable post-dosing visits in body weight [ Time Frame: Day -14 to Day 22 ]*Baseline will be the value of measurement closest to and before start of IP administration.
- Incidence of clinical laboratory abnormalities [ Time Frame: 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.
- Incidence of vital signs abnormalities [ Time Frame: 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.
- Incidence of 12-lead EKG abnormalities [ Time Frame: Day -14 to Day 22 ]EKG measurement will at least include rhythm, ventricular rate, PR interval, QRS duration, QT and QTc intervals
- Incidence of physical examination abnormalities [ Time Frame: 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.
- Concentration of marker ingredient in Careseng 1370, 20(S)-protopanaxadiol (PPD) and its metabolites [ Time Frame: Day -14 to Day 22 ]
- Change in lymphocyte numbers [ Time Frame: Day -14 to Day 22 ]The lymphocyte number will be based on CD3, CD4, CD8, CD19 cell counts.