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出境医 / 临床实验 / Tolerance, PK and PD Effects Study of TPN-672 in Chinese Healthy Volunteers
Tolerance, PK and PD Effects Study of TPN-672 in Chinese Healthy Volunteers
Study Description
Brief Summary:
This is a single-site, randomized, double-blind, placebo-controlled, incremental phase I clinical trial to evaluate preliminarily the tolerance, pharmacokinetics and pharmacodynamic effects of TPN672 maleate in Chinese healthy volunteers after single dose administration.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| PHA1A | Drug: TPN-672 | Early Phase 1 |
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 62 participants |
| Allocation: | Randomized |
| Intervention Model: | Sequential Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Other |
| Official Title: | A Single Site, Randomized, Double-blind, Placebo-controlled, Incremental Phase I Clinical Trial: to Evaluate the Tolerance, PK and PD Effects of TPN-672 Maleate in Chinese Healthy Volunteers After Single Dose Administration. |
| Actual Study Start Date : | April 17, 2019 |
| Estimated Primary Completion Date : | October 17, 2020 |
| Estimated Study Completion Date : | December 17, 2020 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Experimental: 0.125mg single dose
single dose of TPN-672 0.125mg, 2 subjects
|
Drug: TPN-672
single dose of TPN-672 maleate tablet
Other Name: TPN-672 maleate tablet
|
|
Experimental: 0.25mg single dose
single dose of 0.25mg, 10 subjects (8 for TPN-672, 2 for placebo)
|
Drug: TPN-672
single dose of TPN-672 maleate tablet
Other Name: TPN-672 maleate tablet
|
|
Experimental: 0.5mg single dose
single dose of 0.5mg, 10 subjects (8 for TPN-672, 2 for placebo)
|
Drug: TPN-672
single dose of TPN-672 maleate tablet
Other Name: TPN-672 maleate tablet
|
|
Experimental: 1mg single dose
single dose of 1mg, 10 subjects (8 for TPN-672, 2 for placebo)
|
Drug: TPN-672
single dose of TPN-672 maleate tablet
Other Name: TPN-672 maleate tablet
|
|
Experimental: 2mg single dose
single dose of 2mg, 10 subjects (8 for TPN-672, 2 for placebo)
|
Drug: TPN-672
single dose of TPN-672 maleate tablet
Other Name: TPN-672 maleate tablet
|
|
Experimental: 3mg single dose
single dose of 3mg, 10 subjects (8 for TPN-672, 2 for placebo)
|
Drug: TPN-672
single dose of TPN-672 maleate tablet
Other Name: TPN-672 maleate tablet
|
|
Experimental: 4mg single dose
single dose of 4mg, 10 subjects (8 for TPN-672, 2 for placebo)
|
Drug: TPN-672
single dose of TPN-672 maleate tablet
Other Name: TPN-672 maleate tablet
|
Outcome Measures
Primary Outcome Measures :
- Adverse events [ Time Frame: 48 hours ]Number of Subjects with adverse events during clinical trial
- Cmax [ Time Frame: 48 hours ]Maximum Plasma Concentration
- AUC [ Time Frame: 48 hours ]Area Under the Curve
- Tmax [ Time Frame: 48 hours ]Time to Cmax
- T1/2 [ Time Frame: 48 hours ]Time of half life
- ACR [ Time Frame: 48 hours ]Apparent Clearance Rate
- ADV [ Time Frame: 48 hours ]Apparent Distribution Volume
Secondary Outcome Measures :
- prolactin [ Time Frame: 48 hours ]serum prolactin test
- temperature [ Time Frame: 48 hours ]ear temperature
- pulse rate [ Time Frame: 48 hours ]pulse rate
- respiratory [ Time Frame: 48 hours ]frequency of respiratory per minute
- blood pressure [ Time Frame: 48 hours ]lying blood pressure， systolic and diastolic
- electrocardiogram(ECG) [ Time Frame: 48 hours ]the number of subjects with abnormal ECG report by 12-lead electrocardiogram
- QTc [ Time Frame: 48 hours ]QTc interval
- Extrapyramidal symptoms [ Time Frame: 48 hours ]Simpson Angus Rating Scale (SAS), total score ranges from 0 to 40, of which lower values represent a better outcome.
- Involuntary Movement [ Time Frame: 48 hours ]Abnormal Involuntary Movement Scale (AIMS), total score ranges from 0 to 14, of which lower values represent a better outcome.
- Akathisia [ Time Frame: 48 hours ]Barnes Akathisia Rating Scale (BARS), total score ranges from 0 to 40, of which lower values represent a better outcome.
- IL-6 [ Time Frame: 48 hours ]Serum concentration of Interleukin-6
- IL-4 [ Time Frame: 48 hours ]Serum concentration of Interleukin-4
- IL-1 [ Time Frame: 48 hours ]Serum concentration of Interleukin-1
- IL-2 [ Time Frame: 48 hours ]Serum concentration of Interleukin-2
- INF-gamma [ Time Frame: 48 hours ]Serum concentration of Interferon-gamma
- TNF-alpha [ Time Frame: 48 hours ]Serum concentration of Tumor necrosis factor-alpha
- 5-HT [ Time Frame: 48 hours ]Serum concentration of serotonin
- DA [ Time Frame: 48 hours ]Serum concentration of Dopamine
- NE [ Time Frame: 48 hours ]Serum concentration of Norepinephrine
- BDNF [ Time Frame: 48 hours ]Serum concentration of Brain-derived neurotrophic factor
- Glutamic acid [ Time Frame: 48 hours ]Serum concentration of Glutamic acid
- GABA [ Time Frame: 48 hours ]Serum concentration of gamma-aminobutyric acid
Eligibility Criteria
| Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
| Sexes Eligible for Study: | All |
| Gender Based Eligibility: | Yes |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Body weight > 50kg(male) or > 45kg(female), 19 <BMI<26 kg/m2.
- Good communication with investigators, willingness and ability to abide by the lifestyle restrictions stipulated in clinical trial
- Women or men within childbearing age do not have a fertility plan within 3 months after the end of the trial, and agree to adopt contraceptive measures approved (such as intrauterine device, condom, sperm killing gel, condom, uterine cap, etc.) throughout the clinical trial period.
- Fully understand the purpose and requirements of the trial, voluntarily participate in the clinical trial and sign the written informed consent, can complete the entire trial process according to the requirements of the trial.
Exclusion Criteria:
- Investigator determined that there were diseases or functional disorders affecting clinical trials, including, but not limited to, central nervous system, cardiovascular system, respiratory system, digestive system, urinary system, endocrine system and blood system.
- Mental illness or previous history of mental illness;
- Have a history of ophthalmic diseases, such as abnormal color vision, retinitis pigmentosa, macular degeneration, etc.
- Have a history of malignant tumors or other diseases that are not suitable for clinical trials;
- Any surgical condition or condition that may significantly affect drug absorption, distribution, metabolism and excretion, or that may pose a hazard to the subjects participating in the study, such as history of gastrointestinal surgery (gastrectomy, gastrointestinal anastomosis, intestinal resection, etc.), urinary tract obstruction or dysuria, gastroenteritis, gastrointestinal ulcer, gastrointestinal bleeding, etc.
- Those who are known to have a history of drug allergy, allergic disease or allergic constitution of the tested drug ingredients or similar drugs;
- Smokers who smoked more than 10 cigarettes or the same amount of tobacco per day in the first year of screening;
- Alcohol addiction within 1 year before screening, with an average weekly alcohol intake of more than 14 units (1 unit = 285 ml beer or 25 ml spirits or 150 ml wine) or positive alcohol breath test;
- Those who had a history of drug abuse or drug abuse within 1 year before screening, or those who had positive urinary drug screening;
- Physical examination, current medical history and vital signs were found to be abnormal by researchers and have clinical significance.
- Resting pulse rate < 55/min or > 100/min; systolic pressure < 90 mmHg or > 140 mmHg, diastolic pressure < 60 mmHg or > 90 mmHg;
- 12-lead electrocardiogram (ECG) examination was found to be abnormal by investigator and had clinical significance; or the following ECG abnormalities occurred: PR interval > 220 ms, QRS complex wave duration > 120 ms, long QT syndrome (QTc > 450 ms);
- Family history of sudden cardiac death (less than 40 years old);
- Abnormal blood routine examination and urine routine examination have clinical significance.
- Aspartate transferase (AST), alanine transferase (ALT), creatinine (Cr), urea nitrogen (BUN) exceeded the normal upper limit.
- HBsAg, HCV-Ab, HIV-Ab and TRUST positive patients;
- Pregnant or lactating women or male subjects whose spouses have child-rearing plans within three months;
- Those who took any medicine within 2 weeks before admission, including prescription and non-prescription drugs;
- Blood donation or blood loss (> 200 ml) within 3 months before admission, or a history of using blood products;
- Participated in any clinical trials within 3 months before admission;
- Those who had a history of operation within 3 months before admission, or who had not recovered from the operation, or who had anticipated operation plan during the trial period;
- Do not agree to abide by the following conditions during the experiment: prohibit the use of tobacco, alcohol or caffeine-containing beverages, avoid strenuous exercise;
- Personnel directly related to this clinical trial;
- Investigator believes that other subjects are not suitable for the study.
Contacts and Locations
Contacts
| Contact: Yifeng SHEN, MD PhD | 86-21-34773657 | shenyifeng@yahoo.com |
Locations
| China, Shanghai | |
| Shanghai Mental Health Center | Recruiting |
| Shanghai, Shanghai, China, 200030 | |
| Contact: Huafang LI, MD PhD 86-21-34773107 lhlh_5@163.com | |
| Principal Investigator: Huafang LI, MD PhD | |
Sponsors and Collaborators
Shanghai Mental Health Center
Jiangsu Kanion Pharmaceutical Co.
Investigators
| Study Director: | Yifeng SHEN, MD PhD | Shanghai Mental Health Center |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 13, 2019 | ||||
| First Posted Date ICMJE | April 30, 2019 | ||||
| Last Update Posted Date | December 23, 2019 | ||||
| Actual Study Start Date ICMJE | April 17, 2019 | ||||
| Estimated Primary Completion Date | October 17, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Tolerance, PK and PD Effects Study of TPN-672 in Chinese Healthy Volunteers | ||||
| Official Title ICMJE | A Single Site, Randomized, Double-blind, Placebo-controlled, Incremental Phase I Clinical Trial: to Evaluate the Tolerance, PK and PD Effects of TPN-672 Maleate in Chinese Healthy Volunteers After Single Dose Administration. | ||||
| Brief Summary | This is a single-site, randomized, double-blind, placebo-controlled, incremental phase I clinical trial to evaluate preliminarily the tolerance, pharmacokinetics and pharmacodynamic effects of TPN672 maleate in Chinese healthy volunteers after single dose administration. | ||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Early Phase 1 | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Sequential Assignment Masking: Double (Participant, Investigator) Primary Purpose: Other |
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| Condition ICMJE | PHA1A | ||||
| Intervention ICMJE | Drug: TPN-672
single dose of TPN-672 maleate tablet
Other Name: TPN-672 maleate tablet
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* 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 | Unknown status | ||||
| Estimated Enrollment ICMJE |
62 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | December 17, 2020 | ||||
| Estimated Primary Completion Date | October 17, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 45 Years (Adult) | ||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | China | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03931668 | ||||
| Other Study ID Numbers ICMJE | SMHC-180 TPN672-KYHY-201801 ( Other Identifier: Kanion Pharmaceutical ) |
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| Has Data Monitoring Committee | Yes | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Shanghai Mental Health Center | ||||
| Study Sponsor ICMJE | Shanghai Mental Health Center | ||||
| Collaborators ICMJE | Jiangsu Kanion Pharmaceutical Co. | ||||
| Investigators ICMJE |
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| PRS Account | Shanghai Mental Health Center | ||||
| Verification Date | April 2019 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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