SchizophreniaPhase 1NCT05233657
A Safety，Tolerability and Pharmacokinetics Clinical Trial of JX11502MA Capsule
A Phase 1 study testing JX11502MA in people with Schizophrenia, run by Zhejiang Jingxin Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to investigate the safety, tolerability and pharmacokinetic characteristics of JX11502MA capsule on healthy human, and to explore the relationship between the dose, pharmacokinetic parameters and safety of JX11502MA capsule，so as to provide basis for the follow-up clinical trials… 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?
- JX11502MA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteChina
- Study dates
- 4 Jan 2020to 28 Feb 2022
- 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
- Healthy male or female subjects;
- The age is between 18 and 45 years old (including the margin value);
- Male ≥50 kg, female ≥45 kg, the body mass index (BMI) of subjects ranged from 19 to 28 kg/m2 (including the boundary value);
- Be able to understand informed consent, voluntarily participate in clinical trials and sign informed consent;
- Be able to complete the experiment according to the research plan. Those who do not meet one of the above conditions shall not be selected as subjects.
Who cannot join
- The researcher judged that the subjects has current and past medical diseases or dysfunction history that may affect clinical trial, including but not limited to diseases of central nervous system, cardiovascular system, respiratory system, digestive system, urinary system, endocrine system and blood system;
- Suffering from mental illness or previous history of mental illness;
- Have a history of ophthalmic diseases, such as abnormal color vision, retinitis pigmentosa, macular degeneration, etc;
- Have a history of malignant tumors or other diseases that are not suitable for clinical trials;
- Any surgical situation or condition that may significantly affect the absorption, distribution, metabolism and excretion of drugs, or any surgical condition that may harm the subjects participating in this trial; Such as gastrointestinal surgery history (gastrectomy, gastrointestinal anastomosis, intestinal resection, etc.), urinary tract obstruction or dysuria, gastroenteritis, gastrointestinal ulcer, gastrointestinal bleeding history, etc.;
- Those who have allergic history of similar drug, allergic disease history or allergic constitution history;
Show all 24Show fewer
- Those who are addicted to tobacco within one year before screening and smoke more than 10 cigarettes or the same amount of tobacco average every day;
- Those who are addicted to alcohol within one year before screening, and the average weekly alcohol intake exceeds 14 units (1 unit =285 mL beer or 25 mL spirits or 150 mL wine) or those who are positive for alcohol breath test;
- Those who have a history of drug and drug abuse within one year before screening, or those who are positive for urine drug screening;
- Physical examination, present medical history and vital signs, which are judged by researchers to be abnormal and have a clinical significance;
- Resting pulse rate < 55 beats/min or > 100 beats/min; Systolic pressure < 90 mmHg or > 140 mmHg, diastolic pressure < 60 mmHg or > 90 mmHg;
- Abnormal and has a clinical significance of 12-lead electrocardiogram (ECG) examination result judged by researchers; Or appears following ECG abnormalities: PR interval > 220 ms, QRS complex web time limit > 120 ms, long QT syndrome (QTC > 450 ms);
- Family history of sudden cardiac death (Lower than 40 years old);
- Abnormal and have clinical significance of blood routine examination and urine routine examination;
- Exceeded the normal limit of aspartate transferase (AST), alanine transferase (ALT), creatinine (Cr) and urea nitrogen (BUN) .
- Subjects with positive hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), HIV antibody (HIV-Ab) and syphilis seroreaction (TRUST);
- Pregnant and lactating women, or those who have the ability to conceive/pregnant, don't agree to adopt recognize effective methods of contraception during the study period and within 3 months after stopping treatment;
- Those who take any drugs within 2 weeks before before enrolling the trial, including prescription drugs and over-the-counter drugs;
- Blood donation or blood loss ≥200 mL within 3 months before enrolling, or history of using blood products;
- Participated any clinical trial within 3 months before enrolling the trial;
- Those who have a history of surgery within 3 months before enrollment, or haven't recover from surgery, or have expected surgical plan during the trial;
- Don't agree to comply with the following conditions during the trial: prohibit the use of alcohol, tobacco or caffeinated beverages and avoid strenuous exercise;
- Person those are directly related to this trial;
- Researcher decide, subjects those are non-suitable to participate in this trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Mental Health Center
Shanghai
Huafang Li, Doctor, (86)021-34773128
About this study
Official title: An Evaluation of Safety, Tolerability and Pharmacokinetics of Single Oral Dose of JX11502MA Capsule on Healthy Human: A Phase Ia, Single Center, Randomized Clinical Trial
The purpose of this study is to investigate the safety, tolerability and pharmacokinetic characteristics of JX11502MA capsule on healthy human, and to explore the relationship between the dose, pharmacokinetic parameters and safety of JX11502MA capsule，so as to provide basis for the follow-up clinical trials (multi-dose tolerability, pharmacokinetics and phase II trial, etc.).
- Conditions
- Schizophrenia
- Being tested
- JX11502MA, Placebo
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JX11502MADrug
Oral capsule
PlaceboDrug
Oral capsule
| Study group | Role | What they receive |
|---|---|---|
| JX11502MA 0.25mg、0.5mg、1mg、2mg、3mg、6mg、8mg | Experimental | Participants received JX11502MA capsule 0.25mg、0.5mg、1mg、2mg、3mg、6mg、8mg orally administration once, once on an empty stomach in the morning, with about 240ml of warm water. Receives: Drug: JX11502MA |
| Placebo 0.25mg、0.5mg、1mg、2mg、3mg、6mg、8mg | Placebo comparator | Participants received placebo capsule 0.25mg、0.5mg、1mg、2mg、3mg、6mg、8mg orally administration once, once on an empty stomach in the morning, with about 240ml of warm water.. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence rate of adverse reactions
Count the number of subjects with adverse reactions during the trial and calculate the incidence of adverse reactions（Number of subjects with adverse reactions / total number of subjects* 100%）.The adverse reactions include drowsiness、weakness hiccup、vomit、anorexia、nausea、insomnia、dry mouth、dizzy and stomach distention
Measured: Day（1）-Day（7）
Secondary outcomes (4)
Cmax
Maximum Serum Concentration of the parent drug
Measured: Day（1）-Day（7）
Tmax
Time to Reach the Maximum Serum Concentration of the parent drug
Measured: Day（1）-Day（7）
AUC
Area Under the Serum Concentration-Time Curve of the parent drug
Measured: Day（1）-Day（7）
t1/2
Elimination half-life period
Measured: Day（1）-Day（7）
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start4 Jan 2020
- Primary completion31 Jan 2022 (estimated)
- Study completion28 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Jingxin Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05233657
- Sponsor's protocol ID
- JX11502MA-I-01
- Status last verified
- Dec 2021
- First submitted
- 12 Dec 2021
- Last updated
- 10 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yu Y, He J, Huang Z, Li Y, Wu Y, Shen Y, Zhou Y, Bao C, Jin Z, Li H. Safety, tolerability, and pharmacokinetics of JX11502MA in Chinese healthy subjects: a first-in-human, randomized, double-blind, placebo-controlled study following single-dose administration. Expert Opin Investig Drugs. 2024 Jan;33(1):51-61. doi: 10.1080/13543784.2023.2291470. Epub 2024 Feb 12.
PubMed 38054696
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of Safety, Tolerability and Pharmacokinetics of Single Oral Dose of JX11502MA Capsule on Healthy Human: A Phase Ia, Single Center, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05233657
- Acronym / sponsor ID
- JX11502MA-I-01
- Conditions
- Schizophrenia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Zhejiang Jingxin Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Jan 2020 (actual)
- Primary completion
- 31 Jan 2022 (estimated)
- Study completion
- 28 Feb 2022 (estimated)
- First posted
- 10 Feb 2022 (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 purpose of this study is to investigate the safety, tolerability and pharmacokinetic characteristics of JX11502MA capsule on healthy human, and to explore the relationship between the dose, pharmacokinetic parameters and safety of JX11502MA capsule，so as to provide basis for the follow-up clinical trials (multi-dose tolerability, pharmacokinetics and phase II trial, etc.).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JX11502MA 0.25mg、0.5mg、1mg、2mg、3mg、6mg、8mg | Experimental | Drug: JX11502MAParticipants received JX11502MA capsule 0.25mg、0.5mg、1mg、2mg、3mg、6mg、8mg orally administration once, once on an empty stomach in the morning, with about 240ml of warm water. |
| Placebo 0.25mg、0.5mg、1mg、2mg、3mg、6mg、8mg | Placebo comparator | Drug: PlaceboParticipants received placebo capsule 0.25mg、0.5mg、1mg、2mg、3mg、6mg、8mg orally administration once, once on an empty stomach in the morning, with about 240ml of warm water.. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male or female subjects;
- The age is between 18 and 45 years old (including the margin value);
- Male ≥50 kg, female ≥45 kg, the body mass index (BMI) of subjects ranged from 19 to 28 kg/m2 (including the boundary value);
- Be able to understand informed consent, voluntarily participate in clinical trials and sign informed consent;
- Be able to complete the experiment according to the research plan. Those who do not meet one of the above conditions shall not be selected as subjects.
Key exclusion criteria (24 listed)
- The researcher judged that the subjects has current and past medical diseases or dysfunction history that may affect clinical trial, including but not limited to diseases of central nervous system, cardiovascular system, respiratory system, digestive system, urinary system, endocrine system and blood system;
- Suffering from mental illness or previous history of mental illness;
- Have a history of ophthalmic diseases, such as abnormal color vision, retinitis pigmentosa, macular degeneration, etc;
- Have a history of malignant tumors or other diseases that are not suitable for clinical trials;
- Any surgical situation or condition that may significantly affect the absorption, distribution, metabolism and excretion of drugs, or any surgical condition that may harm the subjects participating in this trial; Such as gastrointestinal surgery history (gastrectomy, gastrointestinal anastomosis, intestinal resection, etc.), urinary tract obstruction or dysuria, gastroenteritis, gastrointestinal ulcer, gastrointestinal bleeding history, etc.;
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 |
|---|---|---|
| JX11502MAOral capsule | Drug | JX11502MA 0.25mg、0.5mg、1mg、2mg、3mg、6mg、8mg |
| PlaceboOral capsule | Drug | Placebo 0.25mg、0.5mg、1mg、2mg、3mg、6mg、8mg |
Primary outcome
The incidence rate of adverse reactions
Time frame: Day（1）-Day（7）
Count the number of subjects with adverse reactions during the trial and calculate the incidence of adverse reactions（Number of subjects with adverse reactions / total number of subjects* 100%）.The adverse reactions include drowsiness、weakness hiccup、vomit、anorexia、nausea、insomnia、dry mouth、dizzy and stomach distention
4 secondary outcomes
Cmax
Time frame: Day（1）-Day（7）
Tmax
Time frame: Day（1）-Day（7）
AUC
Time frame: Day（1）-Day（7）
t1/2
Time frame: Day（1）-Day（7）
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2022.
- Derived from this study: PubMed 38054696Yu Y, He J, Huang Z, Li Y, Wu Y, Shen Y, Zhou Y, Bao C, Jin Z, Li H. Safety, tolerability, and pharmacokinetics of JX11502MA in Chinese healthy subjects: a first-in-human, randomized, double-blind, placebo-controlled study following single-dose administration. Expert Opin Investig Drugs. 2024 Jan;33(1):51-61. doi: 10.1080/13543784.2023.2291470. Epub 2024 Feb 12.
- Individual participant dataSharing planned: No
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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.
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 JX11502MA in people with Schizophrenia, run by Zhejiang Jingxin 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 5 inclusion and 24 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 10 Feb 2022. 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. Some participants in this study may receive a placebo. 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 Huafang Li, Doctor (（86）021-34773128, lhlh_5@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence rate of adverse reactions (time frame: Day（1）-Day（7）). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05233657, which also lists 1 linked publication.
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 10 Feb 2022.