Careseng 1370 for Healthy Volunteers

i Cure Biotech Co., Ltd.

Status and phase: Terminated; Phase 1

Conditions: Chemotherapy-induced Myelosuppression

Treatments: Drug: Careseng 1370

Study type: Interventional

Funder types: Industry

Identifiers

NCT03974516

Careseng 1370-01

Details and patient eligibility

About

This study will be performed in healthy volunteers in a conventional 3+3 dose-escalation design.

Full 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).

Enrollment: 13 patients

Sex: All

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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13 participants in 4 patient groups

Careseng 1370 Level A

Experimental group

Description:

Level A (1 sachet): 1 sachet before breakfast. Careseng 1370 granule 4,000 mg sachet consisted of 652 mg (16.3%, w/w) DS-1370 drug substance powder (dry extracts of Panax notoginseng stems and leaves)

Treatment:

Drug: Careseng 1370

Careseng 1370 Level B

Experimental group

Description:

Level B (2 sachets): 1 sachet before breakfast, 1 sachet before lunch. Careseng 1370 granule 4,000 mg sachet consisted of 652 mg (16.3%, w/w) DS-1370 drug substance powder (dry extracts of Panax notoginseng stems and leaves)

Treatment:

Drug: Careseng 1370

Careseng 1370 Level C

Experimental group

Description:

Level C (3 sachets): 1 sachet before breakfast, 2 sachets before lunch. Careseng 1370 granule 4,000 mg sachet consisted of 652 mg (16.3%, w/w) DS-1370 drug substance powder (dry extracts of Panax notoginseng stems and leaves)

Treatment:

Drug: Careseng 1370

Careseng 1370 Level D

Experimental group

Description:

Level D (1 sachet)(modified cohort): 1 sachet before breakfast on 1st, 3rd and 5th days. Careseng 1370 granule 4,000 mg sachet consisted of 652 mg (16.3%, w/w) DS-1370 drug substance powder (dry extracts of Panax notoginseng stems and leaves)

Treatment:

Drug: Careseng 1370