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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

Tolerance, PK and PD Effects Study of TPN-672 in Chinese Healthy Volunteers

Clinicaltrials.gov identifier NCT03931668

Recruitment Status Recruiting

First Posted April 30, 2019

Last update posted December 23, 2019

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:PHA1A
  • Intervention/Treatment: Drug: TPN-672
  • Phase: Early Phase 1
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • 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 2019
  • Estimated Primary Completion Date: October 2020
  • Estimated Study Completion Date: December 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
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
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
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
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
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
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
Outcome Measures
  • Primary Outcome Measures: 1. Adverse events [ Time Frame: 48 hours ]
    Number of Subjects with adverse events during clinical trial
  • 2. Cmax [ Time Frame: 48 hours ]
    Maximum Plasma Concentration
  • 3. AUC [ Time Frame: 48 hours ]
    Area Under the Curve
  • 4. Tmax [ Time Frame: 48 hours ]
    Time to Cmax
  • 5. T1/2 [ Time Frame: 48 hours ]
    Time of half life
  • 6. ACR [ Time Frame: 48 hours ]
    Apparent Clearance Rate
  • 7. ADV [ Time Frame: 48 hours ]
    Apparent Distribution Volume
  • Secondary Outcome Measures: 1. INF-gamma [ Time Frame: 48 hours ]
    Serum concentration of Interferon-gamma
  • 2. TNF-alpha [ Time Frame: 48 hours ]
    Serum concentration of Tumor necrosis factor-alpha
  • 3. 5-HT [ Time Frame: 48 hours ]
    Serum concentration of serotonin
  • 4. DA [ Time Frame: 48 hours ]
    Serum concentration of Dopamine
  • 5. NE [ Time Frame: 48 hours ]
    Serum concentration of Norepinephrine
  • 6. BDNF [ Time Frame: 48 hours ]
    Serum concentration of Brain-derived neurotrophic factor
  • 7. Glutamic acid [ Time Frame: 48 hours ]
    Serum concentration of Glutamic acid
  • 8. GABA [ Time Frame: 48 hours ]
    Serum concentration of gamma-aminobutyric acid
  • 9. QTc [ Time Frame: 48 hours ]
    QTc interval
  • 10. IL-6 [ Time Frame: 48 hours ]
    Serum concentration of Interleukin-6
  • 11. IL-4 [ Time Frame: 48 hours ]
    Serum concentration of Interleukin-4
  • 12. IL-1 [ Time Frame: 48 hours ]
    Serum concentration of Interleukin-1
  • 13. IL-2 [ Time Frame: 48 hours ]
    Serum concentration of Interleukin-2
  • 14. prolactin [ Time Frame: 48 hours ]
    serum prolactin test
  • 15. temperature [ Time Frame: 48 hours ]
    ear temperature
  • 16. pulse rate [ Time Frame: 48 hours ]
    pulse rate
  • 17. respiratory [ Time Frame: 48 hours ]
    frequency of respiratory per minute
  • 18. blood pressure [ Time Frame: 48 hours ]
    lying blood pressure, systolic and diastolic
  • 19. electrocardiogram(ECG) [ Time Frame: 48 hours ]
    the number of subjects with abnormal ECG report by 12-lead electrocardiogram
  • 20. 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.
  • 21. 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.
  • 22. 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.
Eligibility Criteria
  • Ages Eligible for Study: 18 to 45 Years (Adult)
  • Sexes Eligible for Study: All
  • 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 100/min; systolic pressure 140 mmHg,
diastolic pressure 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
Shanghai

Sponsors and Collaborators

Shanghai Mental Health Center

Jiangsu Kanion Pharmaceutical Co.

Investigators

Study Director: Yifeng SHEN, MD PhD Shanghai Mental Health Center

More Information
  • Responsible Party: Shanghai Mental Health Center
  • ClinicalTrials.gov Identifier: NCT03931668 History of Changes
  • Other Study ID Numbers: SMHC-180, TPN672-KYHY-201801
  • First Posted: April 30, 2019 Key Record Dates
  • Last Update Posted: December 23, 2019
  • Last Verified: April 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Shanghai Mental Health Center: tolerance
    pharmacokinetics
    pharmacodynamics
    TPN-672