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 |
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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) |
Primary Purpose: | Treatment |
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 |
Arm | Intervention/treatment |
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Experimental: Careseng 1370
Four dose cohorts are employed for Careseng 1370 oral administration in healthy volunteers:
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Drug: Careseng 1370
Careseng 1370 should be taken around 1 hour before meal.
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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.
Ages Eligible for Study: | 20 Years to 40 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Female volunteer of childbearing potential who:
Note:
Acceptable forms include:
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
No Contacts or Locations Provided
Tracking Information | |||||
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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 |
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 |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures |
Change in lymphocyte numbers [ Time Frame: Day -14 to Day 22 ] The lymphocyte number will be based on CD3, CD4, CD8, CD19 cell counts.
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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). |
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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 |
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Condition ICMJE | Chemotherapy-induced Myelosuppression | ||||
Intervention ICMJE | Drug: Careseng 1370
Careseng 1370 should be taken around 1 hour before meal.
|
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Study Arms ICMJE | Experimental: Careseng 1370
Four dose cohorts are employed for Careseng 1370 oral administration in healthy volunteers:
Intervention: Drug: Careseng 1370
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Not yet recruiting | ||||
Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
Note: Acceptable forms include:
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 |
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Sex/Gender ICMJE |
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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 |
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IPD Sharing Statement ICMJE |
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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 |