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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
Sponsor:
Information provided by (Responsible Party):
Careseng Biotech Co., Ltd.

Tracking Information
First Submitted Date  ICMJE May 30, 2019
First Posted Date  ICMJE June 5, 2019
Last Update Posted Date June 5, 2019
Estimated Study Start Date  ICMJE May 1, 2020
Estimated Primary Completion Date December 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 3, 2019)
Incidence of adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Day -14 to Day 22 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 3, 2019)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 3, 2019)
Change in lymphocyte numbers [ Time Frame: Day -14 to Day 22 ]
The lymphocyte number will be based on CD3, CD4, CD8, CD19 cell counts.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Careseng 1370 for Healthy Volunteers
Official Title  ICMJE A Phase I Dose-Escalation Study in Healthy Volunteers to Evaluate the Safety and Tolerability Profiles of Careseng 1370
Brief Summary

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).

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chemotherapy-induced Myelosuppression
Intervention  ICMJE Drug: Careseng 1370
Careseng 1370 should be taken around 1 hour before meal.
Study Arms  ICMJE Experimental: Careseng 1370

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
Intervention: Drug: Careseng 1370
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 3, 2019)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2022
Estimated Primary Completion Date December 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03974516
Other Study ID Numbers  ICMJE Careseng 1370-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Careseng Biotech Co., Ltd.
Study Sponsor  ICMJE Careseng Biotech Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Careseng Biotech Co., Ltd.
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP