Clinical trial NCT03974516: Careseng 1370 for Healthy Volunteers
Official title: A Phase I Dose-Escalation Study in Healthy Volunteers to Evaluate the Safety and Tolerability Profiles of Careseng 1370
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Chemotherapy-induced Myelosuppression
Lead sponsor: i Cure Biotech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-06-05
Enrollment: 13
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs) and/or Serious Adverse Events (SAEs)
timeFrame: Day -14 to Day 22
Secondary outcomes:
measure: Number of Participants With no Change From Baseline to Applicable Post-dosing Visits in Body Weight (kg)
timeFrame: Day -14 to Day 22
measure: Number of Participants With Clinical Laboratory Abnormalities
timeFrame: Day -14 to Day 22
measure: Number of Participants With Vital Signs Abnormalities
timeFrame: Day -14 to Day 22
measure: Number of Participants With Physical Examination Abnormalities
timeFrame: Day -14 to Day 22
measure: Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites
timeFrame: Day 2 to Day 8
measure: Participants With Abnormal Sinus Rhythm
timeFrame: Day -14 to Day 22
measure: Significantly Abnormal Ventricular Rate Compared to Baseline
timeFrame: Day -14 to Day 22
measure: Significantly Abnormal PR, QRS, QT, QTc Intervals Compared to Baseline
timeFrame: Day -14 to Day 22
Other outcomes:
measure: Number of Participants With Abnormal Immune Profile
timeFrame: Day -14 to Day 22
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University Hospital
Study officials:
References: