SchizophreniaPhase 1NCT04839926
A Single Ascending Dose Study Of CY150112 After Single Oral Administration in Healthy Chinese Subjects
A Phase 1 study testing 0.5mg CY150112, 1.5mg CY150112 and 4.5mg CY150112 in people with Schizophrenia, run by Jiangsu Nhwa Pharmaceutical Co., Ltd. at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- 0.5mg CY150112, 1.5mg CY150112 and 4.5mg CY150112
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 2 Mar 2021to 1 Aug 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- 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.
- 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.
- Subjects who had taken any drugs, including prescription and over-the-counter drugs within 2 weeks prior to enrollment.
- Subjects who directly related to this clinical trial.
- Subjects have poor compliance or other problems that the researchers believe that it is not suitable for participating.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
Hua Fang li, MD, 021-34773107, lhlh_5@163.com
Li Yan, Research Doctor, 021-34773107, lhlh_5@163.com
About this study
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
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.
Read the 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 ).
- Conditions
- Schizophrenia
- Being tested
- 0.5mg CY150112, 1.5mg CY150112, 4.5mg CY150112, 10mg CY150112, 18mg CY150112
- Keywords
- Safety, Tolerability,Pharmacokinetics, CY150112, Single Ascending Dose
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.5mg CY150112Drug
Also called placebo
single oral CY150112 while fasting on day 1.
1.5mg CY150112Drug
Also called placebo
single oral CY150112 while fasting on day 1.
4.5mg CY150112Drug
Also called placebo
single oral CY150112 while fasting on day 1.
10mg CY150112Drug
Also called placebo
single oral CY150112 while fasting on day 1.
18mg CY150112Drug
Also called placebo
single oral CY150112 while fasting on day 1.
24mg CY150112Drug
Also called placebo
single oral CY150112 while fasting on day 1.
| Study group | Role | What they receive |
|---|---|---|
| 0.5mg CY150112 | Experimental | single oral CY150112 while fasting on day 1. Receives: Drug: 0.5mg CY150112 |
| 1.5mg CY150112 | Experimental | single oral CY150112 while fasting on day 1. Receives: Drug: 1.5mg CY150112 |
| 4.5mg CY150112 | Experimental | single oral CY150112 while fasting on day 1. Receives: Drug: 4.5mg CY150112 |
| 10mg CY150112 | Experimental | single oral CY150112 while fasting on day 1. Receives: Drug: 10mg CY150112 |
| 18mg CY150112 | Experimental | single oral CY150112 while fasting on day 1. Receives: Drug: 18mg CY150112 |
| 24mg CY150112 | Experimental | single oral CY150112 while fasting on day 1. Receives: Drug: 24mg CY150112 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of AEs
Incidence of Adverse Events
Measured: 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
Maximum (peak) observed drug serum concentration
Measured: 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
Area under the concentration-time curve from time zero (pre-dose) to the time of the dosing interval
Measured: pre-dose（within1hour）,0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
AUC0-∞
Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time
Measured: pre-dose（within1hour）,0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
%AUCex
Extrapolation percentage of AUC0-∞
Measured: pre-dose（within1hour）,0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
Tmax
Time of occurrence of Cmax
Measured: pre-dose（within1hour）,0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
T1/2
Biological half life correlated with the elimination rate constant (kel) of semi-logarithmic concentration-time curve
Measured: pre-dose（within1hour）,0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
Vd
Apparent volume of distribution
Measured: pre-dose（within1hour）,0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
CL
Clearance
Measured: pre-dose（within1hour）,0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
λz
Elimination rate constant
Measured: pre-dose（within1hour）,0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start2 Mar 2021
- Primary completion1 Aug 2021 (estimated)
- Study completion1 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Nhwa Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hua Fang li, MD, Principal investigator, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04839926
- Sponsor's protocol ID
- NH101-11
- Status last verified
- Apr 2021
- First submitted
- 6 Apr 2021
- Last updated
- 9 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04839926
- Acronym / sponsor ID
- NH101-11
- Conditions
- Schizophrenia
- Keywords
- Safety, Tolerability,Pharmacokinetics, CY150112, Single Ascending Dose
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Jiangsu Nhwa Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Mar 2021 (actual)
- Primary completion
- 1 Aug 2021 (estimated)
- Study completion
- 1 Aug 2021 (estimated)
- First posted
- 9 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 ).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 0.5mg CY150112 | Experimental | Drug: 0.5mg CY150112single oral CY150112 while fasting on day 1. |
| 1.5mg CY150112 | Experimental | Drug: 1.5mg CY150112single oral CY150112 while fasting on day 1. |
| 4.5mg CY150112 | Experimental | Drug: 4.5mg CY150112single oral CY150112 while fasting on day 1. |
| 10mg CY150112 | Experimental | Drug: 10mg CY150112single oral CY150112 while fasting on day 1. |
| 18mg CY150112 | Experimental | Drug: 18mg CY150112single oral CY150112 while fasting on day 1. |
| 24mg CY150112 | Experimental | Drug: 24mg CY150112single oral CY150112 while fasting on day 1. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.5mg CY150112Also: placebosingle oral CY150112 while fasting on day 1. | Drug | 0.5mg CY150112 |
| 1.5mg CY150112Also: placebosingle oral CY150112 while fasting on day 1. | Drug | 1.5mg CY150112 |
| 4.5mg CY150112Also: placebosingle oral CY150112 while fasting on day 1. | Drug | 4.5mg CY150112 |
| 10mg CY150112Also: placebosingle oral CY150112 while fasting on day 1. | Drug | 10mg CY150112 |
| 18mg CY150112Also: placebosingle oral CY150112 while fasting on day 1. | Drug | 18mg CY150112 |
| 24mg CY150112Also: placebosingle oral CY150112 while fasting on day 1. | Drug | 24mg CY150112 |
Primary outcome
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
9 secondary outcomes
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
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
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
%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
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
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hua Fang li, MD principal investigator
Shanghai Mental Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 0.5mg CY150112, 1.5mg CY150112 and 4.5mg CY150112 in people with Schizophrenia, run by Jiangsu Nhwa Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hua Fang li, MD (021-34773107, lhlh_5@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2021.