Careseng 1370 for Healthy Volunteers

Study Overview
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Brief Summary
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This study will be performed in healthy volunteers in a conventional 3+3 dose-escalation design. Four cohorts (dose level A, B, C, and D) of up to 6 evaluable volunteers per cohort are planned to be sequentially accrued to receive Careseng 1370 1, 2, 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).

Official Title
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A Phase I Dose-Escalation Study in Healthy Volunteers to Evaluate the Safety and Tolerability Profiles of Careseng 1370

Conditions
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Chemotherapy-induced Myelosuppression

Intervention / Treatment
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* Drug: Careseng 1370


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult aged between 20-40 years old (inclusive) 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. Body Mass Index (BMI) between 18.5 and 24, inclusive (BMI will be calculated as weight in kilogram [kg]/(height in meters)2 [m2]) 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. Volunteer is willing and able to comply with study procedures and sign informed consent prior to initiation of any study-mandated procedures. Exclusion Criteria: Volunteer who has a history or evidence of a medical condition that would expose them to a risk of a significant adverse event or interfere with the assessments of safety or pharmacodynamics variables during the course of the trial, including but not limited to hepatic, renal, respiratory, cardiovascular, endocrine, immune, neurological, musculoskeletal or hematological disease as determined by the clinical judgment of the investigator Volunteer has received any other investigational agent within 28 days prior to the first dose of study drug Volunteer has taken or potentially takes any herbal medication/supplements/medicinal food, prescription medication and/or over-the-counter medication within 2 weeks prior to the first dose of study drug Volunteer has alcohol, caffeine, grapefruit juice, or nicotine consumption within 24 hours prior to the first dose of study drug Female volunteer of childbearing potential who: 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: Established use of oral, injected or implanted hormonal methods of contraception. Placement of an intrauterine device (IUD) or intrauterine system (IUS). 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Careseng 1370<br>Four dose cohorts are employed for Careseng 1370 oral administration in healthy volunteers: Level A (1 sachet): 1 sachet before breakfast; Level B (2 sachets): 1 sachet before breakfast, 1 sachet before lunch; Level C (3 sachets): 1 sachet before breakfast, 2 sachets before lunch; Level D (4 sachets): 2 sachets before breakfast, 2 sachets before lunch | Drug: Careseng 1370<br>* Careseng 1370 should be taken around 1 hour before meal.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events (AEs) and serious adverse events (SAEs) |  | Day -14 to Day 22 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline to applicable post-dosing visits in body weight | *Baseline will be the value of measurement closest to and before start of IP administration. | Day -14 to Day 22 | 
| Incidence of clinical laboratory abnormalities | The laboratory examinations include Hematology tests (CBC, PT and aPTT), Biochemistry (AST, ALP, ALT, bilirubin, creatinine, BUN, CRP, total protein, r-GT, lipid and electrolytes) and Urinalysis (pH, protein, RBC, WBC and urine cast). *Baseline will be the value of measurement closest to and before start of IP administration. | Day -14 to Day 22 | 
| Incidence of vital signs abnormalities | Vital signs measurement will consist of systolic/diastolic blood pressure, respiratory rate, pulse rate or heart rate, and body temperature. | Day -14 to Day 22 | 
| Incidence of 12-lead EKG abnormalities | EKG measurement will at least include rhythm, ventricular rate, PR interval, QRS duration, QT and QTc intervals | Day -14 to Day 22 | 
| Incidence of physical examination abnormalities | Physical examination will include the following items: general appearance, skin, eyes, ears, nose, throat, head and neck, heart, chest and lungs, abdomen, extremities, lymph nodes, musculoskeletal, neurological and others. | Day -14 to Day 22 | 
| Concentration of marker ingredient in Careseng 1370, 20(S)-protopanaxadiol (PPD) and its metabolites |  | Day -14 to Day 22 |