Chemotherapy-induced MyelosuppressionPhase 1NCT03974516
Careseng 1370 for Healthy Volunteers
A Phase 1 study testing Careseng 1370 in people with Chemotherapy-induced Myelosuppression, run by i Cure Biotech Co., Ltd. at 1 site in Taiwan.
Trial summary
This study will be performed in healthy volunteers in a conventional 3+3 dose-escalation design. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Chemotherapy-induced Myelosuppression
- What is being tested?
- Careseng 1370
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Aug 2020to 11 Mar 2022
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult aged between 20-40 years old (inclusive)
- 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.
- Body Mass Index (BMI) between 18.5 and 24, inclusive (BMI will be calculated as weight in kilogram [kg]/(height in meters)2 [m2])
- 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.
- Volunteer is willing and able to comply with study procedures and sign informed consent prior to initiation of any study-mandated procedures.
Who cannot join
- 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
- Volunteer has received any other investigational agent within 28 days prior to the first dose of study drug
- 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
- Volunteer has alcohol, caffeine, grapefruit juice, or nicotine consumption within 24 hours prior to the first dose of study drug
- Female volunteer of childbearing potential who:
- is lactating; or
Show all 23Show fewer
- 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:
- Established use of oral, injected or implanted hormonal methods of contraception.
- Placement of an intrauterine device (IUD) or intrauterine system (IUS).
- Barrier methods of contraception: Condom OR Occlusive cap (diaphragm or cervical/vault caps)
- 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
- Known or suspected allergy or hypersensitivity to any ingredients of study product
- With history of stroke, myocardial infarction, or Coronary Artery Bypass Graft (CABG) surgery within the last 6 months prior to the screening visit
- 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
- With blood pressures as systolic blood pressure < 90 mmHg or > 170 mmHg or diastolic blood pressure < 50 mmHg or > 120 mmHg at eligibility checking
- History of psychiatric disorder
- History of left ventricular outflow obstruction, such as aortic stenosis and hypertrophic cardiomyopathy
- With a history of human immunodeficiency virus (HIV) infection or hepatitis B or C infection
- Plan to receive surgery from Screening visit until Final visit
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Chemotherapy-induced Myelosuppression
- Being tested
- Careseng 1370
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Careseng 1370Drug
Careseng 1370 should be taken around 1 hour before meal.
| Study group | Role | What they receive |
|---|---|---|
| Careseng 1370 Level A | Experimental | 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) Receives: Drug: Careseng 1370 |
| Careseng 1370 Level B | Experimental | 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) Receives: Drug: Careseng 1370 |
| Careseng 1370 Level C | Experimental | 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) Receives: Drug: Careseng 1370 |
| Careseng 1370 Level D | Experimental | 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) Receives: Drug: Careseng 1370 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day -14 to Day 22
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 2 to Day 8
Participants With Abnormal Sinus Rhythm
Sinus rhythm was measured by 12-lead EKG
Measured: Day -14 to Day 22
Significantly Abnormal Ventricular Rate Compared to Baseline
Ventricular rate was measured by EKG.
Measured: 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.
Measured: Day -14 to Day 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2019
- Study start10 Aug 2020
- Primary completion11 Mar 2022
- Study completion11 Mar 2022
Why it stopped: This study was early terminated by the sponsor considering the difficulty of subject recruitment in the pandemic of COVID-19.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chemotherapy-induced MyelosuppressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- i Cure Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03974516
- Sponsor's protocol ID
- Careseng 1370-01
- Status last verified
- Sep 2024
- First submitted
- 30 May 2019
- Last updated
- 22 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Dose-Escalation Study in Healthy Volunteers to Evaluate the Safety and Tolerability Profiles of Careseng 1370
- ClinicalTrials.gov ID
- NCT03974516
- Acronym / sponsor ID
- Careseng 1370-01
- Conditions
- Chemotherapy-induced Myelosuppression
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was early terminated by the sponsor considering the difficulty of subject recruitment in the pandemic of COVID-19.
- Enrolment
- 13 participants (actual)
- Lead sponsor
- i Cure Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Aug 2020 (actual)
- Primary completion
- 11 Mar 2022 (actual)
- Study completion
- 11 Mar 2022 (actual)
- First posted
- 5 Jun 2019 (actual)
- Results
- Posted 22 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Careseng 1370 Level A | Experimental | Drug: Careseng 1370Level 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) |
| Careseng 1370 Level B | Experimental | Drug: Careseng 1370Level 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) |
| Careseng 1370 Level C | Experimental | Drug: Careseng 1370Level 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) |
| Careseng 1370 Level D | Experimental | Drug: Careseng 1370Level 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) |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adult aged between 20-40 years old (inclusive)
- 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.
- Body Mass Index (BMI) between 18.5 and 24, inclusive (BMI will be calculated as weight in kilogram [kg]/(height in meters)2 [m2])
- 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.
- Volunteer is willing and able to comply with study procedures and sign informed consent prior to initiation of any study-mandated procedures.
Key exclusion criteria (23 listed)
- 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
- Volunteer has received any other investigational agent within 28 days prior to the first dose of study drug
- 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
- Volunteer has alcohol, caffeine, grapefruit juice, or nicotine consumption within 24 hours prior to the first dose of study drug
- Female volunteer of childbearing potential who:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Careseng 1370Careseng 1370 should be taken around 1 hour before meal. | Drug | Careseng 1370 Level A, Careseng 1370 Level B, Careseng 1370 Level C, Careseng 1370 Level D |
Primary outcome
Number of Participants With Adverse Events (AEs) and/or Serious Adverse Events (SAEs)
Time frame: Day -14 to Day 22
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.
8 secondary outcomes
Number of Participants With no Change From Baseline to Applicable Post-dosing Visits in Body Weight (kg)
Time frame: Day -14 to Day 22
Number of Participants With Clinical Laboratory Abnormalities
Time frame: Day -14 to Day 22
Number of Participants With Vital Signs Abnormalities
Time frame: Day -14 to Day 22
Number of Participants With Physical Examination Abnormalities
Time frame: Day -14 to Day 22
Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites
Time frame: Day 2 to Day 8
Participants With Abnormal Sinus Rhythm
Time frame: Day -14 to Day 22
Significantly Abnormal Ventricular Rate Compared to Baseline
Time frame: Day -14 to Day 22
Significantly Abnormal PR, QRS, QT, QTc Intervals Compared to Baseline
Time frame: Day -14 to Day 22
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Careseng 1370 in people with Chemotherapy-induced Myelosuppression, run by i Cure Biotech Co., Ltd. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events (AEs) and/or Serious Adverse Events (SAEs) (time frame: Day -14 to Day 22). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2024.