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

NCT04839926 | Unknown Phase 1 DMC

• 1 other identifier: NH101-11
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Keywords

Safety, Tolerability,Pharmacokinetics; CY150112; Single Ascending Dose

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Cmax

  pre-dose（within1hour）,0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose

• AUC0-t

  pre-dose（within1hour）,0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose

• AUC0-∞

  pre-dose（within1hour）,0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose

• %AUCex

  pre-dose（within1hour）,0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose

• Tmax

  pre-dose（within1hour）,0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose

Study Arms (6)

0.5mg CY150112

EXPERIMENTAL

single oral CY150112 while fasting on day 1.

Drug: 0.5mg CY150112

1.5mg CY150112

EXPERIMENTAL

single oral CY150112 while fasting on day 1.

Drug: 1.5mg CY150112

4.5mg CY150112

EXPERIMENTAL

single oral CY150112 while fasting on day 1.

Drug: 4.5mg CY150112

10mg CY150112

EXPERIMENTAL

single oral CY150112 while fasting on day 1.

Drug: 10mg CY150112

18mg CY150112

EXPERIMENTAL

single oral CY150112 while fasting on day 1.

Drug: 18mg CY150112

24mg CY150112

EXPERIMENTAL

single oral CY150112 while fasting on day 1.

Drug: 24mg CY150112

Interventions

0.5mg CY150112 DRUG

single oral CY150112 while fasting on day 1.

Also known as: placebo

0.5mg CY150112

1.5mg CY150112 DRUG

single oral CY150112 while fasting on day 1.

Also known as: placebo

1.5mg CY150112

4.5mg CY150112 DRUG

single oral CY150112 while fasting on day 1.

Also known as: placebo

4.5mg CY150112

10mg CY150112 DRUG

single oral CY150112 while fasting on day 1.

Also known as: placebo

10mg CY150112

18mg CY150112 DRUG

single oral CY150112 while fasting on day 1.

Also known as: placebo

18mg CY150112

24mg CY150112 DRUG

single oral CY150112 while fasting on day 1.

Also known as: placebo

24mg CY150112

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male/female subjects are 18\<age ≤45 years of age when signing the informed consent.
• 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.
• 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.
• 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.

You may not qualify if:

• 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.
• 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.
• Subjects with past history of allergy to drugs or allergic disease.
• Subjects with currently or past history of mental disorders and brain functional disorders.
• 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.
• Subjects have history of drug abuse or positive urine drug tests at screening within 1 year prior.
• 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.
• Average amount of daily smoking\>5 cigarettes at screening 3 months prior.
• Those who have special requirements for food, cannot follow a uniform diet or have difficulty swallowing.
• 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.
• 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 ).
• Subjects who resting heart rate \<55 beats/min or \>100 beats/min; systolic blood pressure \<90mmHg or \>140mmHg; diastolic blood pressure \<60mmHg or \>90mmHg.
• 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.
• 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.
• Subjects who participated in any clinical trial within 3 months before medication.

Sponsors & Collaborators

• Jiangsu Nhwa Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Hua Fang li, MD

  Shanghai Mental Health Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hua Fang li, MD

CONTACT

021-34773107; lhlh_5@163.com

Li Yan, Research Doctor

CONTACT

021-34773107; lhlh_5@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2021
• First Posted: April 9, 2021
• Study Start: March 2, 2021
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: April 9, 2021

Record last verified: 2021-04

Locations

CN (1)