Clinical trial NCT04839926: A Single Ascending Dose Study Of CY150112 After Single Oral Administration in Healthy Chinese Subjects
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Schizophrenia
Keywords: Safety, Tolerability,Pharmacokinetics
CY150112
Single Ascending Dose
Lead sponsor: Jiangsu Nhwa Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-04-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

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.

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 ).

Eligibility 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.

Primary outcomes:
measure: Incidence of AEs
timeFrame: pre-dose（within1hour）,0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
Secondary outcomes:
measure: Cmax
timeFrame: pre-dose（within1hour）,0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
measure: AUC0-t
timeFrame: pre-dose（within1hour）,0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
measure: AUC0-∞
timeFrame: pre-dose（within1hour）,0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
measure: %AUCex
timeFrame: pre-dose（within1hour）,0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
measure: Tmax
timeFrame: pre-dose（within1hour）,0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
measure: T1/2
timeFrame: pre-dose（within1hour）,0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
measure: Vd
timeFrame: pre-dose（within1hour）,0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
measure: CL
timeFrame: pre-dose（within1hour）,0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
measure: λz
timeFrame: pre-dose（within1hour）,0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Mental Health Center
state: Shanghai
Study officials:
affiliation: Shanghai Mental Health Center
name: Hua Fang li, MD
role: PRINCIPAL_INVESTIGATOR
References: