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A Single Ascending Dose Study Of CY150112 After Single Oral Administration in Healthy Chinese Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04839926
Recruitment Status : Recruiting
First Posted : April 9, 2021
Last Update Posted : April 9, 2021
Sponsor:
Information provided by (Responsible Party):
Jiangsu Nhwa Pharmaceutical Co., Ltd.

Study Description
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Brief Summary:
The primary objective of single ascending dose study is to evaluate the safety and tolerability of CY150112 after single oral administration of different doses in healthy Chinese subjects.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: 0.5mg CY150112 Drug: 1.5mg CY150112 Drug: 4.5mg CY150112 Drug: 10mg CY150112 Drug: 18mg CY150112 Drug: 24mg CY150112 Phase 1

Detailed Description:

Single administration, double-blinded, placebo-controlled (2 subjects in each group will take placebo,8 subjects in each group will take CY150112) and 6 dose groups (0.5mg, 1.5mg, 4.5mg, 10mg, 18mg and 24mg).

This study comprises a screening period (between signing of the informed consent form and Day -1), baseline period (Day -1), treatment period (Days 1-5) and follow-up period(Days 12 or 7 days after discharge ).

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Phase I Clinical Trial to Evaluate Safety, Tolerability, and Pharmacokinetics of CY150112 After Single Oral Administration in Healthy Chinese Subjects
Actual Study Start Date : March 2, 2021
Estimated Primary Completion Date : August 1, 2021
Estimated Study Completion Date : August 1, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 0.5mg CY150112
single oral CY150112 while fasting on day 1.
 Drug: 0.5mg CY150112
single oral CY150112 while fasting on day 1.
Other Name: placebo
Experimental: 1.5mg CY150112
single oral CY150112 while fasting on day 1.
 Drug: 1.5mg CY150112
single oral CY150112 while fasting on day 1.
Other Name: placebo
Experimental: 4.5mg CY150112
single oral CY150112 while fasting on day 1.
 Drug: 4.5mg CY150112
single oral CY150112 while fasting on day 1.
Other Name: placebo
Experimental: 10mg CY150112
single oral CY150112 while fasting on day 1.
 Drug: 10mg CY150112
single oral CY150112 while fasting on day 1.
Other Name: placebo
Experimental: 18mg CY150112
single oral CY150112 while fasting on day 1.
 Drug: 18mg CY150112
single oral CY150112 while fasting on day 1.
Other Name: placebo
Experimental: 24mg CY150112
single oral CY150112 while fasting on day 1.
 Drug: 24mg CY150112
single oral CY150112 while fasting on day 1.
Other Name: placebo


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of AEs [ Time Frame: pre-dose（within1hour）,0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose ]
    Incidence of Adverse Events


Secondary Outcome Measures :
  1. Cmax [ Time Frame: pre-dose（within1hour）,0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose ]
    Maximum (peak) observed drug serum concentration

  2. AUC0-t [ Time Frame: pre-dose（within1hour）,0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose ]
    Area under the concentration-time curve from time zero (pre-dose) to the time of the dosing interval

  3. AUC0-∞ [ Time Frame: pre-dose（within1hour）,0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose ]
    Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time

  4. %AUCex [ Time Frame: pre-dose（within1hour）,0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose ]
    Extrapolation percentage of AUC0-∞

  5. Tmax [ Time Frame: pre-dose（within1hour）,0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose ]
    Time of occurrence of Cmax

  6. T1/2 [ Time Frame: pre-dose（within1hour）,0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose ]
    Biological half life correlated with the elimination rate constant (kel) of semi-logarithmic concentration-time curve

  7. Vd [ Time Frame: pre-dose（within1hour）,0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose ]
    Apparent volume of distribution

  8. CL [ Time Frame: pre-dose（within1hour）,0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose ]
    Clearance

  9. λz [ Time Frame: pre-dose（within1hour）,0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose ]
    Elimination rate constant


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male/female subjects are 18<age ≤45 years of age when signing the informed consent.
  2. Male Subjects with body weight of ≥50.0kg ，and female Subjects with body weight of ≥45.0kg and BMI (body mass index) of 18.5≤ and <28.0 at screening examination.
  3. After detailed explanations of study objectives, contents and procedures, and possible risks, subjects are aware of all relevant information related to this study and have signed the written informed consent form voluntarily.
  4. Subjects are able to communicate well with researchers, be willing and able to comply with the lifestyle restrictions stipulated during this study period, and cooperate to complete this study.

Exclusion Criteria:

  1. The investigator determined that the subjects' present medical history and past medical history had any disease or dysfunction that would affect the clinical trial, including but not limited to diseases of the central nervous system, cardiovascular system, respiratory system, digestive system, urinary system, endocrine system, hematological system, etc.
  2. There is any surgical condition or disease that may significantly affect the absorption, distribution, metabolism and excretion of drugs, or may harm to the subjects participating in the trial; such as history of gastrointestinal operations (gastrectomy, gastroenterostomy, enterectomy, etc.), urinary tract obstruction or dysuria, gastroenteritis, digestive tract ulcers, history of gastrointestinal bleeding, etc.
  3. Subjects with past history of allergy to drugs or allergic disease.
  4. Subjects with currently or past history of mental disorders and brain functional disorders.
  5. According to the Columbia suicide severity scale (C-SSRS), subjects were at risk of suicide or were at risk of suicide based on the clinical judgment of the researchers, or with past history of self-injurious behavior.
  6. Subjects have history of drug abuse or positive urine drug tests at screening within 1 year prior.
  7. Subjects have history of alcohol abuse(i.e.,criteria are per week consumption more than 14 standard units(1 unit =360mL beer or 45mL 40% alcohol of Chinese liquor or 150mL wine)or positive alcohol breath tests at screening within 1 year prior.
  8. Average amount of daily smoking>5 cigarettes at screening 3 months prior.
  9. Those who have special requirements for food, cannot follow a uniform diet or have difficulty swallowing.
  10. Female subjects who are pregnant and lactating ; and those who refuse to use effective non-drug contraceptive measures (such as abstinence, intrauterine device) or have planned to donate sperm or ovum throughout the study period and within 3 months after the end of the study.
  11. Abnormal vital signs, lab and ECG indicators, as determined by the researcher, and clinically significant (e.g., male QTC > 450ms female > 470ms,corrected by Friericia ).
  12. Subjects who resting heart rate <55 beats/min or >100 beats/min; systolic blood pressure <90mmHg or >140mmHg; diastolic blood pressure <60mmHg or >90mmHg.
  13. Subjects who hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCV-Ab), or HIV antibody (HIV-Ab), or syphilis serum reaction (TRUST) is non-negative.
  14. Subjects who glutamic-pyruvic transaminase(ALT), creatinine (Cr), urea nitrogen (BUN) exceeding the normal upper limit or the level of serum prolactin is 2 times higher than the normal upper limit.
  15. Subjects who participated in any clinical trial within 3 months before medication.
  16. Subjects have history of blood donations of 400 mL within 3 months before enrollment; 200 mL within 1 month before enrollment; or have history of using blood products.
  17. Subjects who had a history of surgery within 3 months prior to enrollment, or did not recover from surgery, or had an expected surgical plan during the study period.
  18. Subjects who had taken any drugs, including prescription and over-the-counter drugs within 2 weeks prior to enrollment.
  19. Subjects who directly related to this clinical trial.
  20. Subjects have poor compliance or other problems that the researchers believe that it is not suitable for participating.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04839926


Contacts
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Contact: Hua Fang li, MD 021-34773107 lhlh_5@163.com
Contact: Li Yan, Research Doctor 021-34773107 lhlh_5@163.com

Locations
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China, Shanghai
Shanghai Mental Health Center Recruiting
Shanghai, Shanghai, China, 200030
Contact: Hua Fang li, MD    021-34773107    lhlh_5@163.com   
Contact: Li Yan, Research Doctor    021-34773107    lhlh_5@163.com   
Principal Investigator: Hua Fang Li, MD         
Sub-Investigator: Li Yan, Research Doctor         
Sponsors and Collaborators
Jiangsu Nhwa Pharmaceutical Co., Ltd.
Investigators
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Principal Investigator: Hua Fang li, MD Shanghai Mental Health Center
More Information
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Responsible Party: Jiangsu Nhwa Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT04839926    
Other Study ID Numbers: NH101-11
First Posted: April 9, 2021    Key Record Dates
Last Update Posted: April 9, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jiangsu Nhwa Pharmaceutical Co., Ltd.:
Safety, Tolerability,Pharmacokinetics
CY150112
Single Ascending Dose
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders