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

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04839926
• Other study ID #: NH101-11
• Status: Recruiting
• Phase: Phase 1
• Start date: March 2, 2021
• Est. completion date: August 1, 2021

Study information

• Verified date: April 2021
• Source: Jiangsu Nhwa Pharmaceutical Co., Ltd.
• Contact: Hua Fang li, MD
• Phone: 021-34773107
• Email: lhlh_5[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 ).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 1, 2021
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• 0.5mg CY150112
single oral CY150112 while fasting on day 1.
• 1.5mg CY150112
single oral CY150112 while fasting on day 1.
• 4.5mg CY150112
single oral CY150112 while fasting on day 1.
• 10mg CY150112
single oral CY150112 while fasting on day 1.
• 18mg CY150112
single oral CY150112 while fasting on day 1.
• 24mg CY150112
single oral CY150112 while fasting on day 1.

Locations

Country	Name	City	State
China	Shanghai Mental Health Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Nhwa Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of AEs	Incidence of Adverse Events	pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
Secondary	Cmax	Maximum (peak) observed drug serum concentration	pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
Secondary	AUC0-t	Area under the concentration-time curve from time zero (pre-dose) to the time of the dosing interval	pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
Secondary	AUC0-8	Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time	pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
Secondary	%AUCex	Extrapolation percentage of AUC0-8	pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
Secondary	Tmax	Time of occurrence of Cmax	pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
Secondary	T1/2	Biological half life correlated with the elimination rate constant (kel) of semi-logarithmic concentration-time curve	pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
Secondary	Vd	Apparent volume of distribution	pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
Secondary	CL	Clearance	pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
Secondary	?z	Elimination rate constant	pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose