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A Single Ascending Dose Study Of CY150112 After Single Oral Administration in Healthy Chinese Subjects | Clinical Trials | Clareo Health

UNKNOWNPHASE1

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

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

NCT04839926•Jiangsu Nhwa Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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

Age

18 - 45 years

Sex

ALL

Healthy Volunteers

Yes

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.
+10 more criteria

Locations (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

March 2, 2021

Primary Completion Date

August 1, 2021

Completion Date

August 1, 2021

Last Updated

April 9, 2021

Enrollment

ESTIMATED participants

Conditions

Schizophrenia

Interventions

0.5mg CY150112

DRUG

1.5mg CY150112

DRUG

4.5mg CY150112

DRUG

10mg CY150112

DRUG

18mg CY150112

DRUG

24mg CY150112

DRUG

Contacts

Hua Fang li, MD

CONTACT

021-34773107 lhlh_5@163.com

Li Yan, Research Doctor

CONTACT

021-34773107 lhlh_5@163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 9, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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