HealthyPhase 1NCT04164290
A Study to Evaluate the Tolerability and Pharmacokinetics of Jiashen Tablets in Healthy Subjects
A Phase 1 study testing Jiashen Tablets in people with Healthy, run by Tasly Pharmaceutical Group Co., Ltd at 1 site in China.
Trial summary
Jiashen Tablets as an oral, compound traditional chinese medicine prepatations, have an effect on improvement of the heart failure. This study will assess the safety, tolerability and pharmacokinetics (PK) of Jiashen Tablets, following oral administration of single and multiple ascending dose of Jiashen Tablets. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Jiashen Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 29 Jun 2020to 9 Apr 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers, half male and half female, aged 18-50 years (including the boundary value), the age difference of the same batch of subjects should not exceed 10 years.
- Have a body mass index of all subjects between 19 and 24kg /m2 (inclusive) and weight of the male subject should be no less than 50Kg and the weight of the female subject should be no less than 45Kg.
- Passed the smoke test, alcohol and drug abuse test, general physical examination and laboratory examination, chest film, ultrasound, electrocardiogram and other physical and chemical tests.
- No history of major diseases, no history of smoking and drinking, negative blood pregnancy test of women of childbearing age and no lactation.
- Obtain informed consent and volunteer to be tested in accordance with the provisions of the Drug clinical trial quality management standard.
Who cannot join
- Have primary diseases of cardiovascular，hepatic or renal disease or any other condition. With history of digestive tract diseases, metabolic diseases, and neurological diseases.
- QTc extension (male >430ms, female >450ms).
- History of drug allergy or allergic constitution.
- Family history of hypokalemia, long QT syndrome or other TdP risk factors.
- Mentally or physically disabled.
- Any clinically significant abnormalities in physical examination, biochemical and hematuria routine examination, electrocardiogram, chest film and ultrasound examination,.
Show all 19Show fewer
- Any positive result on Screening for serum hepatitis B tests (except surface antibodies), hepatitis C antibody , human immunodeficiency virus (HIV) and treponema pallidum antibody test.
- Those who had taken a drug known to damage an organ within 3 months, taken any drug within 2 weeks, and participated in other clinical trials within 4 weeks.
- Bleeding tendency.
- Women during menstruation, pregnancy and lactation.
- Abnormal vital signs (systolic pressure <90mmHg or >140mmHg, diastolic pressure <60mmHg or >90mmHg;Heart rate <60bpm or >100bpm).
- Have smoked more than one cigarette per day or used a considerable amount of nicotine products within the previous 3 months, and could not quit smoking during the experiment. Positive screen for the smoke test.
- Regular drinkers who drank more than 14 units of alcohol per week (1 unit =360mL beer or 45mL spirits with a 40% alcohol content or 150mL wine) during the 6 months prior to the trial, or who tested positive for alcohol, or who do not abstain during the trial.
- Excessive daily consumption of tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup =250mL) or caffeine test positive.
- Have a history of blood transfusion or donation in the last 3 months (blood volume greater than 200mL).
- Have a history of drug abuse and tested positive for drug abuse (morphine, methamphetamine, ketamine, dimethyldimethamphetamine, THC, cocaine).
- Have a history of antibiotic use in the last month.
- Have taken lactobacillus products (including yogurt) in the last week.
- Judgment by the Investigator that the participant should not participate in the study (such as weak, etc).
Trial locations and contacts
1 site in 1 country.
China1 site
The second affiliated hospital of tianjin university of traditional Chinese medicine
Tianjin, Tianjin Municipality
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics of Jiashen Tablets in Healthy Subjects
Jiashen Tablets as an oral, compound traditional chinese medicine prepatations, have an effect on improvement of the heart failure. This study will assess the safety, tolerability and pharmacokinetics (PK) of Jiashen Tablets, following oral administration of single and multiple ascending dose of Jiashen Tablets.
Read the detailed description
This study will include a randomized, double-blind, placebo-controlled, single ascending dose design study (Part A), and an open-label SDAD pre-multiple daily ascending dose (MDAD) study (Part B) and an open-label MDAD study (Part C) study.
The study will be conducted in healthy participants and performed at a single study center. 70 healthy participants are planned to be included in the study.
Part A will include six cohorts, 40 participants. Within each cohort, 2 participants will be randomized to receive placebo and other participants randomized to receive Jiashen Tablets. Each participant will receive Jiashen Tablets at the selected dose level or placebo by oral administration in a fasted state once daily.
Part B will include two cohorts, 6 participants, minimum dose group and maximum dose group respectively depending on the findings. Within each cohort, participant will receive Jiashen Tablets at the selected dose level by oral administration in a fasted state once daily.
Part C will include three cohorts, 24 participants. Within each cohort, participant will receive Jiashen Tablets at the selected dose level by oral administration in a fasted state once daily for 7 days.
- Conditions
- Healthy
- Being tested
- Jiashen Tablets, Jiashen Tablets Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jiashen TabletsDrug
Also called treatment group 1
1 tablet
Jiashen TabletsDrug
Also called treatment group 2
2 tablets
Jiashen TabletsDrug
Also called treatment group 3
4 tablets
Jiashen TabletsDrug
Also called treatment group 4
6 tablets
Jiashen TabletsDrug
Also called treatment group 5
8 tablets
Jiashen TabletsDrug
Also called treatment group 6
9 tablets
Jiashen Tablets PlaceboDrug
Also called control group 1
1 tablet
Jiashen Tablets PlaceboDrug
Also called control group 2
2 tablets
Jiashen Tablets PlaceboDrug
Also called control group 3
4 tablets
Jiashen Tablets PlaceboDrug
Also called control group 4
6 tablets
Jiashen Tablets PlaceboDrug
Also called control group 5
8 tablets
Jiashen Tablets PlaceboDrug
Also called control group 6
9 tablets
| Study group | Role | What they receive |
|---|---|---|
| treatment group 1 | Active comparator | Jiashen tablet, 0.47g, oral, once a day Receives: Drug: Jiashen Tablets |
| treatment group 2 | Active comparator | Jiashen tablet, 0.94g, oral, once a day Receives: Drug: Jiashen Tablets |
| treatment group 3 | Active comparator | Jiashen tablet,1.88g, oral, once a day Receives: Drug: Jiashen Tablets |
| treatment group 4 | Active comparator | Jiashen tablet,2.82g, oral, once a day Receives: Drug: Jiashen Tablets |
| treatment group 5 | Active comparator | Jiashen tablet,3.76g, oral, once a day Receives: Drug: Jiashen Tablets |
| treatment group 6 | Active comparator | Jiashen tablet,4.23g, oral, once a day Receives: Drug: Jiashen Tablets |
| control group 1 | Placebo comparator | Jiashen placebo tablet,0.47g, oral, once a day Receives: Drug: Jiashen Tablets Placebo |
| control group 2 | Placebo comparator | Jiashen placebo tablet,0.94g, oral, once a day Receives: Drug: Jiashen Tablets Placebo |
| control group 3 | Placebo comparator | Jiashen placebo tablet,1.88g, oral, once a day Receives: Drug: Jiashen Tablets Placebo |
| control group 4 | Placebo comparator | Jiashen placebo tablet,2.82g, oral, once a day Receives: Drug: Jiashen Tablets Placebo |
| control group 5 | Placebo comparator | Jiashen placebo tablet,3.76g, oral, once a day Receives: Drug: Jiashen Tablets Placebo |
| control group 6 | Placebo comparator | Jiashen placebo tablet,4.23g, oral, once a day Receives: Drug: Jiashen Tablets Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events (AEs)
To investigate the safety and tolerability of Jiashen Tablets following oral administration of single and multiple ascending doses at steady state in healthy participants. Serious AEs will be recorded from the time of screening.
Measured: From screening (Day-7) till follow-up visit (Up to 1 week)
Number of participants with abnormal blood pressure (BP)
To investigate the safety and tolerability of Jiashen Tablets following oral administration of single and multiple ascending doses at steady state in healthy participants. Blood pressure includes both systolic and diastolic BP.
Measured: From screening (Day-7) till follow-up visit (Up to 1 week)
Number of participants with abnormal pulse
To investigate the safety and tolerability of Jiashen Tablets following oral administration of single and multiple ascending doses at steady state in healthy participants.
Measured: From screening (Day-7) till follow-up visit (Up to 1 week)
Number of participants with abnormal temperature
To investigate the safety and tolerability of Jiashen Tablets following oral administration of single and multiple ascending doses at steady state in healthy participants.
Measured: From screening (Day-7) till follow-up visit (Up to 1 week)
Number of participants with abnormal respiratory
To investigate the safety and tolerability of Jiashen Tablets following oral administration of single and multiple ascending doses at steady state in healthy participants.
Measured: From screening (Day-7) till follow-up visit (Up to 1 week)
Number of participants with abnormal findings in 12-lead safety Electrocardiogram (ECG)
To investigate the safety and tolerability of Jiashen Tablets following oral administration of single and multiple ascending doses at steady state in healthy participants.
Measured: From screening (Day-7) till follow-up visit (Up to 1 week)
Number of participants with abnormal findings in 24h Holter
To investigate the safety and tolerability of Jiashen Tablets following oral administration of single and multiple ascending doses at steady state in healthy participants.
Measured: From screening (Day -1) till end of trial period
Number of participants with abnormal physical examination findings
To investigate the safety and tolerability of Jiashen Tablets following oral administration of single and multiple ascending doses at steady state in healthy Japanese participants. The complete physical examinations will include an assessment of the general appearance, skin, cardiovascular, abdomen, head, and neck, lymph nodes, musculoskeletal and neurological systems.
Measured: From screening (Day -1) till follow-up visit (Up to 1 week)
Number of participants with abnormal laboratory assessments: Hematology - absolute count of Red blood cell (RBC), White blood cell (WBC), Platelets
To investigate the safety and tolerability of Jiashen Tablets following oral administration of single and multiple ascending doses at steady state in healthy participants.
Measured: From screening (Day -1) till follow-up visit (Up to 1 week)
Number of participants with abnormal laboratory assessments: Hematology-Hematocrit (HCT)
To investigate the safety and tolerability of Jiashen Tablets following oral administration of single and multiple ascending doses at steady state in healthy participants.
Measured: From screening (Day -1) till follow-up visit (Up to 1 week)
Number of participants with abnormal laboratory assessments: Hematology - Hemoglobin (Hb)
To investigate the safety and tolerability of Jiashen Tablets following oral administration of single and multiple ascending doses at steady state in healthy participants.
Measured: From screening (Day -1) till follow-up visit (Up to 1 week)
Number of participants with abnormal laboratory assessments: Hematology-percentage of Basophils, Eosinophils, Monocytes, Neutrophils, Lymphocytes
To investigate the safety and tolerability of Jiashen Tablets following oral administration of single and multiple ascending doses at steady state in healthy participants.
Measured: From screening (Day -1) till follow-up visit (Up to 1 week)
Number of participants with abnormal laboratory assessments: Clinical Chemistry- Liver function, Renal function, Electrolyte
To investigate the safety and tolerability of Jiashen Tablets following oral administration of single and multiple ascending doses at steady state in healthy participants. Liver function: Alanine aminotransferase, Aspartate aminotransferase,Alkaline phosphatase, Gamma-glutamyltransferase,Total Bilirubin, Direct Bilirubin. Renal function: Creatinine,Urea,β2-microglobulin. Electrolyte: Potassium,Sodium,Chloridion,Calcium.
Measured: From screening (Day -1) till follow-up visit (Up to 1 week)
Number of participants with abnormal laboratory assessments: Urinalysis - Urine leukocyte, urine erythrocyte,specific grvity,Glucose, Protein, urobilinogen,bilirubin, ketone, bacteria
To investigate the safety and tolerability of Jiashen Tablets following oral administration of single and multiple ascending doses at steady state in healthy participants
Measured: From screening (Day -1) till follow-up visit (Up to 1 week)
Number of participants with abnormal laboratory assessments: coagulation function -Prothrombin Time, Activated Partial Thromboplastin Time,Thrombin Time,Fibrinogen, International Normalized Ratio
To investigate the safety and tolerability of Jiashen Tablets following oral administration of single and multiple ascending doses at steady state in healthy participants
Measured: From screening (Day -1) till follow-up visit (Up to 1 week)
Number of participants with abnormal laboratory assessments: Fecal -Fecal Routine and Occult Blood
To investigate the safety and tolerability of Jiashen Tablets following oral administration of single and multiple ascending doses at steady state in healthy participants
Measured: From screening (Day -1) till follow-up visit (Up to 1 week)
Secondary outcomes (9)
Plasma PK analysis: Area under curve at steady state (AUCss)
To characterize the multiple dose PK of Jiashen Tablets and assess the time required to reach steady state, the degree of accumulation and the time dependency of the PK in healthy participants.
Measured: Day 1,7/8: Pre-dose and 0.5,1.0,1.5,2.0,3.0,4.0,5.0,6.0,7.0,8.0,9.0,10,12,16,24,36,48 hours post-dose and Day 5-6/6-7: Pre-dose
Plasma PK analysis: Maximum observed plasma concentration (Cmax)
To characterize the multiple dose PK of Jiashen Tablets and assess the time required to reach steady state, the degree of accumulation and the time dependency of the PK in healthy participants.
Measured: Day 1,7/8: Pre-dose and 0.5,1.0,1.5,2.0,3.0,4.0,5.0,6.0,7.0,8.0,9.0,10,12,16,24,36,48 hours post-dose and Day 5-6/6-7: Pre-dose
Plasma PK analysis: Time to reach peak or maximum observed concentration following drug administration (tmax)
To characterize the multiple dose PK of Jiashen Tablets and assess the time required to reach steady state, the degree of accumulation and the time dependency of the PK in healthy participants.
Measured: Day 1,7/8: Pre-dose and 0.5,1.0,1.5,2.0,3.0,4.0,5.0,6.0,7.0,8.0,9.0,10,12,16,24,36,48 hours post-dose and Day 5-6/6-7: Pre-dose
Plasma PK analysis: Apparent total body clearance of drug from plasma after extravascular administration (CL/F)
To characterize the multiple dose PK of Jiashen Tablets and assess the time required to reach steady state, the degree of accumulation and the time dependency of the PK in healthy participants.
Measured: Day 1,7/8: Pre-dose and 0.5,1.0,1.5,2.0,3.0,4.0,5.0,6.0,7.0,8.0,9.0,10,12,16,24,36,48 hours post-dose and Day 5-6/6-7: Pre-dose
Plasma PK analysis: Observed concentration at the end of the dosing interval following drug administration at steady state (Cssmin)
To characterize the multiple dose PK of Jiashen Tablets and assess the time required to reach steady state, the degree of accumulation and the time dependency of the PK in healthy participants.
Measured: Day 1,7/8: Pre-dose and 0.5,1.0,1.5,2.0,3.0,4.0,5.0,6.0,7.0,8.0,9.0,10,12,16,24,36,48 hours post-dose and Day 5-6/6-7: Pre-dose
Plasma PK analysis: Elimination half-life(t1/2)
To characterize the multiple dose PK of Jiashen Tablets and assess the time required to reach steady state, the degree of accumulation and the time dependency of the PK in healthy participants.
Measured: Day 1,7/8: Pre-dose and 0.5,1.0,1.5,2.0,3.0,4.0,5.0,6.0,7.0,8.0,9.0,10,12,16,24,36,48 hours post-dose and Day 5-6/6-7: Pre-dose
Plasma PK analysis: Maximum observed plasma concentration at steady state (Cmax,ss), time to reach peak or maximum observed concentration following drug administration at steady state (tmax,ss)
To characterize the multiple dose PK of Jiashen Tablets and assess the time required to reach steady state, the degree of accumulation and the time dependency of the PK in healthy participants.
Measured: Day 1,7/8: Pre-dose and 0.5,1.0,1.5,2.0,3.0,4.0,5.0,6.0,7.0,8.0,9.0,10,12,16,24,36,48 hours post-dose and Day 5-6/6-7: Pre-dose
Plasma PK analysis: Terminal elimination rate constant, estimated by log-linear least squares regression of the terminal part of the concentration-time curve following drug administration (λz)
To characterize the multiple dose PK of Jiashen Tablets and assess the time required to reach steady state, the degree of accumulation and the time dependency of the PK in healthy participants.
Measured: Day 1,7/8: Pre-dose and 0.5,1.0,1.5,2.0,3.0,4.0,5.0,6.0,7.0,8.0,9.0,10,12,16,24,36,48 hours post-dose and Day 5-6/6-7: Pre-dose
Plasma PK analysis: Terminal half-life, estimated as (ln2)/λz (t½λz)
To characterize the multiple dose PK of Jiashen Tablets and assess the time required to reach steady state, the degree of accumulation and the time dependency of the PK in healthy participants.
Measured: Day 1,7/8: Pre-dose and 0.5,1.0,1.5,2.0,3.0,4.0,5.0,6.0,7.0,8.0,9.0,10,12,16,24,36,48 hours post-dose and Day 5-6/6-7: Pre-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2019
- Study start29 Jun 2020
- Primary completion9 Apr 2021
- Study completion9 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Tasly Pharmaceutical Group Co., LtdThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tasly Pharmaceutical Group Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rui Liu, Study director, Tasly Group, Co. Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04164290
- Sponsor's protocol ID
- TSL-TCM-JSP-I
- Status last verified
- Nov 2022
- First submitted
- 12 Nov 2019
- Last updated
- 23 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics of Jiashen Tablets in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04164290
- Acronym / sponsor ID
- TSL-TCM-JSP-I
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Tasly Pharmaceutical Group Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 29 Jun 2020 (actual)
- Primary completion
- 9 Apr 2021 (actual)
- Study completion
- 9 Apr 2021 (actual)
- First posted
- 15 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Jiashen Tablets as an oral, compound traditional chinese medicine prepatations, have an effect on improvement of the heart failure. This study will assess the safety, tolerability and pharmacokinetics (PK) of Jiashen Tablets, following oral administration of single and multiple ascending dose of Jiashen Tablets.
Detailed description
This study will include a randomized, double-blind, placebo-controlled, single ascending dose design study (Part A), and an open-label SDAD pre-multiple daily ascending dose (MDAD) study (Part B) and an open-label MDAD study (Part C) study.
The study will be conducted in healthy participants and performed at a single study center. 70 healthy participants are planned to be included in the study.
Part A will include six cohorts, 40 participants. Within each cohort, 2 participants will be randomized to receive placebo and other participants randomized to receive Jiashen Tablets. Each participant will receive Jiashen Tablets at the selected dose level or placebo by oral administration in a fasted state once daily.
Part B will include two cohorts, 6 participants, minimum dose group and maximum dose group respectively depending on the findings. Within each cohort, participant will receive Jiashen Tablets at the selected dose level by oral administration in a fasted state once daily.
Part C will include three cohorts, 24 participants. Within each cohort, participant will receive Jiashen Tablets at the selected dose level by oral administration in a fasted state once daily for 7 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| treatment group 1 | Active comparator | Drug: Jiashen TabletsJiashen tablet, 0.47g, oral, once a day |
| treatment group 2 | Active comparator | Drug: Jiashen TabletsJiashen tablet, 0.94g, oral, once a day |
| treatment group 3 | Active comparator | Drug: Jiashen TabletsJiashen tablet,1.88g, oral, once a day |
| treatment group 4 | Active comparator | Drug: Jiashen TabletsJiashen tablet,2.82g, oral, once a day |
| treatment group 5 | Active comparator | Drug: Jiashen TabletsJiashen tablet,3.76g, oral, once a day |
| treatment group 6 | Active comparator | Drug: Jiashen TabletsJiashen tablet,4.23g, oral, once a day |
| control group 1 | Placebo comparator | Drug: Jiashen Tablets PlaceboJiashen placebo tablet,0.47g, oral, once a day |
| control group 2 | Placebo comparator | Drug: Jiashen Tablets PlaceboJiashen placebo tablet,0.94g, oral, once a day |
| control group 3 | Placebo comparator | Drug: Jiashen Tablets PlaceboJiashen placebo tablet,1.88g, oral, once a day |
| control group 4 | Placebo comparator | Drug: Jiashen Tablets PlaceboJiashen placebo tablet,2.82g, oral, once a day |
| control group 5 | Placebo comparator | Drug: Jiashen Tablets PlaceboJiashen placebo tablet,3.76g, oral, once a day |
| control group 6 | Placebo comparator | Drug: Jiashen Tablets PlaceboJiashen placebo tablet,4.23g, oral, once a day |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy volunteers, half male and half female, aged 18-50 years (including the boundary value), the age difference of the same batch of subjects should not exceed 10 years.
- Have a body mass index of all subjects between 19 and 24kg /m2 (inclusive) and weight of the male subject should be no less than 50Kg and the weight of the female subject should be no less than 45Kg.
- Passed the smoke test, alcohol and drug abuse test, general physical examination and laboratory examination, chest film, ultrasound, electrocardiogram and other physical and chemical tests.
- No history of major diseases, no history of smoking and drinking, negative blood pregnancy test of women of childbearing age and no lactation.
- Obtain informed consent and volunteer to be tested in accordance with the provisions of the Drug clinical trial quality management standard.
Key exclusion criteria (19 listed)
- Have primary diseases of cardiovascular，hepatic or renal disease or any other condition. With history of digestive tract diseases, metabolic diseases, and neurological diseases.
- QTc extension (male >430ms, female >450ms).
- History of drug allergy or allergic constitution.
- Family history of hypokalemia, long QT syndrome or other TdP risk factors.
- Mentally or physically disabled.
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 |
|---|---|---|
| Jiashen TabletsAlso: treatment group 11 tablet | Drug | treatment group 1 |
| Jiashen TabletsAlso: treatment group 22 tablets | Drug | treatment group 2 |
| Jiashen TabletsAlso: treatment group 34 tablets | Drug | treatment group 3 |
| Jiashen TabletsAlso: treatment group 46 tablets | Drug | treatment group 4 |
| Jiashen TabletsAlso: treatment group 58 tablets | Drug | treatment group 5 |
| Jiashen TabletsAlso: treatment group 69 tablets | Drug | treatment group 6 |
| Jiashen Tablets PlaceboAlso: control group 11 tablet | Drug | control group 1 |
| Jiashen Tablets PlaceboAlso: control group 22 tablets | Drug | control group 2 |
| Jiashen Tablets PlaceboAlso: control group 34 tablets | Drug | control group 3 |
| Jiashen Tablets PlaceboAlso: control group 46 tablets | Drug | control group 4 |
| Jiashen Tablets PlaceboAlso: control group 58 tablets | Drug | control group 5 |
| Jiashen Tablets PlaceboAlso: control group 69 tablets | Drug | control group 6 |
Primary outcome
Number of participants with adverse events (AEs)
Time frame: From screening (Day-7) till follow-up visit (Up to 1 week)
To investigate the safety and tolerability of Jiashen Tablets following oral administration of single and multiple ascending doses at steady state in healthy participants. Serious AEs will be recorded from the time of screening.
Number of participants with abnormal blood pressure (BP)
Time frame: From screening (Day-7) till follow-up visit (Up to 1 week)
To investigate the safety and tolerability of Jiashen Tablets following oral administration of single and multiple ascending doses at steady state in healthy participants. Blood pressure includes both systolic and diastolic BP.
Number of participants with abnormal pulse
Time frame: From screening (Day-7) till follow-up visit (Up to 1 week)
To investigate the safety and tolerability of Jiashen Tablets following oral administration of single and multiple ascending doses at steady state in healthy participants.
Number of participants with abnormal temperature
Time frame: From screening (Day-7) till follow-up visit (Up to 1 week)
To investigate the safety and tolerability of Jiashen Tablets following oral administration of single and multiple ascending doses at steady state in healthy participants.
Number of participants with abnormal respiratory
Time frame: From screening (Day-7) till follow-up visit (Up to 1 week)
To investigate the safety and tolerability of Jiashen Tablets following oral administration of single and multiple ascending doses at steady state in healthy participants.
Number of participants with abnormal findings in 12-lead safety Electrocardiogram (ECG)
Time frame: From screening (Day-7) till follow-up visit (Up to 1 week)
To investigate the safety and tolerability of Jiashen Tablets following oral administration of single and multiple ascending doses at steady state in healthy participants.
Number of participants with abnormal findings in 24h Holter
Time frame: From screening (Day -1) till end of trial period
To investigate the safety and tolerability of Jiashen Tablets following oral administration of single and multiple ascending doses at steady state in healthy participants.
Number of participants with abnormal physical examination findings
Time frame: From screening (Day -1) till follow-up visit (Up to 1 week)
To investigate the safety and tolerability of Jiashen Tablets following oral administration of single and multiple ascending doses at steady state in healthy Japanese participants. The complete physical examinations will include an assessment of the general appearance, skin, cardiovascular, abdomen, head, and neck, lymph nodes, musculoskeletal and neurological systems.
Number of participants with abnormal laboratory assessments: Hematology - absolute count of Red blood cell (RBC), White blood cell (WBC), Platelets
Time frame: From screening (Day -1) till follow-up visit (Up to 1 week)
To investigate the safety and tolerability of Jiashen Tablets following oral administration of single and multiple ascending doses at steady state in healthy participants.
Number of participants with abnormal laboratory assessments: Hematology-Hematocrit (HCT)
Time frame: From screening (Day -1) till follow-up visit (Up to 1 week)
To investigate the safety and tolerability of Jiashen Tablets following oral administration of single and multiple ascending doses at steady state in healthy participants.
Number of participants with abnormal laboratory assessments: Hematology - Hemoglobin (Hb)
Time frame: From screening (Day -1) till follow-up visit (Up to 1 week)
To investigate the safety and tolerability of Jiashen Tablets following oral administration of single and multiple ascending doses at steady state in healthy participants.
Number of participants with abnormal laboratory assessments: Hematology-percentage of Basophils, Eosinophils, Monocytes, Neutrophils, Lymphocytes
Time frame: From screening (Day -1) till follow-up visit (Up to 1 week)
To investigate the safety and tolerability of Jiashen Tablets following oral administration of single and multiple ascending doses at steady state in healthy participants.
Number of participants with abnormal laboratory assessments: Clinical Chemistry- Liver function, Renal function, Electrolyte
Time frame: From screening (Day -1) till follow-up visit (Up to 1 week)
To investigate the safety and tolerability of Jiashen Tablets following oral administration of single and multiple ascending doses at steady state in healthy participants. Liver function: Alanine aminotransferase, Aspartate aminotransferase,Alkaline phosphatase, Gamma-glutamyltransferase,Total Bilirubin, Direct Bilirubin. Renal function: Creatinine,Urea,β2-microglobulin. Electrolyte: Potassium,Sodium,Chloridion,Calcium.
Number of participants with abnormal laboratory assessments: Urinalysis - Urine leukocyte, urine erythrocyte,specific grvity,Glucose, Protein, urobilinogen,bilirubin, ketone, bacteria
Time frame: From screening (Day -1) till follow-up visit (Up to 1 week)
To investigate the safety and tolerability of Jiashen Tablets following oral administration of single and multiple ascending doses at steady state in healthy participants
Number of participants with abnormal laboratory assessments: coagulation function -Prothrombin Time, Activated Partial Thromboplastin Time,Thrombin Time,Fibrinogen, International Normalized Ratio
Time frame: From screening (Day -1) till follow-up visit (Up to 1 week)
To investigate the safety and tolerability of Jiashen Tablets following oral administration of single and multiple ascending doses at steady state in healthy participants
Number of participants with abnormal laboratory assessments: Fecal -Fecal Routine and Occult Blood
Time frame: From screening (Day -1) till follow-up visit (Up to 1 week)
To investigate the safety and tolerability of Jiashen Tablets following oral administration of single and multiple ascending doses at steady state in healthy participants
9 secondary outcomes
Plasma PK analysis: Area under curve at steady state (AUCss)
Time frame: Day 1,7/8: Pre-dose and 0.5,1.0,1.5,2.0,3.0,4.0,5.0,6.0,7.0,8.0,9.0,10,12,16,24,36,48 hours post-dose and Day 5-6/6-7: Pre-dose
Plasma PK analysis: Maximum observed plasma concentration (Cmax)
Time frame: Day 1,7/8: Pre-dose and 0.5,1.0,1.5,2.0,3.0,4.0,5.0,6.0,7.0,8.0,9.0,10,12,16,24,36,48 hours post-dose and Day 5-6/6-7: Pre-dose
Plasma PK analysis: Time to reach peak or maximum observed concentration following drug administration (tmax)
Time frame: Day 1,7/8: Pre-dose and 0.5,1.0,1.5,2.0,3.0,4.0,5.0,6.0,7.0,8.0,9.0,10,12,16,24,36,48 hours post-dose and Day 5-6/6-7: Pre-dose
Plasma PK analysis: Apparent total body clearance of drug from plasma after extravascular administration (CL/F)
Time frame: Day 1,7/8: Pre-dose and 0.5,1.0,1.5,2.0,3.0,4.0,5.0,6.0,7.0,8.0,9.0,10,12,16,24,36,48 hours post-dose and Day 5-6/6-7: Pre-dose
Plasma PK analysis: Observed concentration at the end of the dosing interval following drug administration at steady state (Cssmin)
Time frame: Day 1,7/8: Pre-dose and 0.5,1.0,1.5,2.0,3.0,4.0,5.0,6.0,7.0,8.0,9.0,10,12,16,24,36,48 hours post-dose and Day 5-6/6-7: Pre-dose
Plasma PK analysis: Elimination half-life(t1/2)
Time frame: Day 1,7/8: Pre-dose and 0.5,1.0,1.5,2.0,3.0,4.0,5.0,6.0,7.0,8.0,9.0,10,12,16,24,36,48 hours post-dose and Day 5-6/6-7: Pre-dose
Plasma PK analysis: Maximum observed plasma concentration at steady state (Cmax,ss), time to reach peak or maximum observed concentration following drug administration at steady state (tmax,ss)
Time frame: Day 1,7/8: Pre-dose and 0.5,1.0,1.5,2.0,3.0,4.0,5.0,6.0,7.0,8.0,9.0,10,12,16,24,36,48 hours post-dose and Day 5-6/6-7: Pre-dose
Plasma PK analysis: Terminal elimination rate constant, estimated by log-linear least squares regression of the terminal part of the concentration-time curve following drug administration (λz)
Time frame: Day 1,7/8: Pre-dose and 0.5,1.0,1.5,2.0,3.0,4.0,5.0,6.0,7.0,8.0,9.0,10,12,16,24,36,48 hours post-dose and Day 5-6/6-7: Pre-dose
Plasma PK analysis: Terminal half-life, estimated as (ln2)/λz (t½λz)
Time frame: Day 1,7/8: Pre-dose and 0.5,1.0,1.5,2.0,3.0,4.0,5.0,6.0,7.0,8.0,9.0,10,12,16,24,36,48 hours post-dose and Day 5-6/6-7: Pre-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2022.
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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.
Rui Liu study director
Tasly Group, Co. Ltd.
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 Jiashen Tablets in people with Healthy, run by Tasly Pharmaceutical Group Co., Ltd at 1 site in China.
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 19 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: finished, as of the sponsor's last update on 23 Nov 2022. 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 China. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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) (time frame: From screening (Day-7) till follow-up visit (Up to 1 week)). The study lists 16 primary outcomes in all. 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 23 Nov 2022.