Careseng 1370 for Healthy Volunteers

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

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

Study Overview

• Status: Terminated
• Conditions: Chemotherapy-induced Myelosuppression
• Intervention / Treatment: Drug: Careseng 1370

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).

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 1

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Taipei Medical University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Careseng 1370 Level A; 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)	Drug: Careseng 1370; Careseng 1370 should be taken around 1 hour before meal.
Experimental: Careseng 1370 Level B; 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)	Drug: Careseng 1370; Careseng 1370 should be taken around 1 hour before meal.
Experimental: Careseng 1370 Level C; 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)	Drug: Careseng 1370; Careseng 1370 should be taken around 1 hour before meal.
Experimental: Careseng 1370 Level D; 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)	Drug: Careseng 1370; Careseng 1370 should be taken around 1 hour before meal.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adverse Events (AEs) and/or Serious Adverse Events (SAEs)	An AE is any untoward medical occurrence in a volunteer or clinical investigation participant administered a study medication and that does not necessarily have a causal relationship with this treatment. Laboratory abnormalities should not be recorded as AE unless determined to be clinically significant by Investigator. A SAE is defined as an AE meeting one of the following conditions: Death during the period of protocol defined surveillance; Life Threatening Event (defined as a participant at immediate risk of death at the time of the event); An event requiring in volunteer hospitalization or prolongation of existing hospitalization during the period of protocol defined surveillance; Results in congenital anomaly or birth defect; Results in a persistent or significant disability/incapacity; Based upon appropriate medical judgment, the event may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed above.	Day -14 to Day 22

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With no Change From Baseline to Applicable Post-dosing Visits in Body Weight (kg)	*Baseline will be the value of measurement closest to and before start of IP administration. "Body weight unchanged from Baseline to Day X" indicates that the body weight on Day X minus the body weight at baseline has a 95% confidence interval that includes zero.	Day -14 to Day 22
Number of Participants With 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
Number of Participants With 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
Number of Participants With 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
Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites	Maximum plasma concentration (Cmax) of PPD and its metabolites, M-C1, and M-C2.	Day 2 to Day 8
Participants With Abnormal Sinus Rhythm	Sinus rhythm was measured by 12-lead EKG	Day -14 to Day 22
Significantly Abnormal Ventricular Rate Compared to Baseline	Ventricular rate was measured by EKG.	Day -14 to Day 22
Significantly Abnormal PR, QRS, QT, QTc Intervals Compared to Baseline	PR, QRS, QT and QTc intervals were measured by EKG.	Day -14 to Day 22

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Abnormal Immune Profile	Immune profile includes percentages of CD3+, CD3+/CD4+, CD3+/CD8+, CD19+, CD16+/CD56+, and CD4/CD8 ratio	Day -14 to Day 22

Collaborators and Investigators

• Sponsor: i Cure Biotech Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2020
• Primary Completion (Actual): March 11, 2022
• Study Completion (Actual): March 11, 2022

Study Registration Dates

• First Submitted: May 30, 2019
• First Submitted That Met QC Criteria: June 3, 2019
• First Posted (Actual): June 5, 2019

Study Record Updates

• Last Update Posted (Estimated): November 22, 2024
• Last Update Submitted That Met QC Criteria: September 27, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: Careseng 1370-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No