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Status unknownNCT05233657Updated Feb 10, 2022

A Safety,Tolerability and Pharmacokinetics Clinical Trial of JX11502MA Capsule

A Phase 1 interventional study of JX11502MA and Placebo in Schizophrenia, sponsored by Zhejiang Jingxin Pharmaceutical Co., Ltd.. Status unknown at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-02-10.

Sponsored by Zhejiang Jingxin Pharmaceutical Co., Ltd. · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2021), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 1 year 11 months after the study started (first participant enrolled Jan 2020, registered Dec 2021).
Phase
Phase 1
Study type
Interventional
Enrollment
58
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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 (multi-dose tolerability, pharmacokinetics and phase II trial, etc.).

02

Conditions studied

  • Schizophrenia

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03

In context

Schizophrenia

3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.

This study's planned enrollment of 58 is below the median of 70 across 2,872 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

Zhejiang Jingxin Pharmaceutical Co., Ltd. is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Healthy male or female subjects;
  2. The age is between 18 and 45 years old (including the margin value);
  3. Male ≥50 kg, female ≥45 kg, the body mass index (BMI) of subjects ranged from 19 to 28 kg/m2 (including the boundary value);
  4. Be able to understand informed consent, voluntarily participate in clinical trials and sign informed consent;
  5. 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.

Exclusion criteria

Exclusion Criteria:

  1. 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;
  2. Suffering from mental illness or previous history of mental illness;
  3. Have a history of ophthalmic diseases, such as abnormal color vision, retinitis pigmentosa, macular degeneration, etc;
  4. Have a history of malignant tumors or other diseases that are not suitable for clinical trials;
  5. 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.;
  6. Those who have allergic history of similar drug, allergic disease history or allergic constitution history;
  7. 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;
  8. 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;
  9. Those who have a history of drug and drug abuse within one year before screening, or those who are positive for urine drug screening;
  10. Physical examination, present medical history and vital signs, which are judged by researchers to be abnormal and have a clinical significance;
  11. Resting pulse rate \< 55 beats/min or > 100 beats/min; Systolic pressure \< 90 mmHg or > 140 mmHg, diastolic pressure \< 60 mmHg or > 90 mmHg;
  12. 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);
  13. Family history of sudden cardiac death (Lower than 40 years old);
  14. Abnormal and have clinical significance of blood routine examination and urine routine examination;
  15. Exceeded the normal limit of aspartate transferase (AST), alanine transferase (ALT), creatinine (Cr) and urea nitrogen (BUN) .
  16. Subjects with positive hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), HIV antibody (HIV-Ab) and syphilis seroreaction (TRUST);
  17. 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;
  18. Those who take any drugs within 2 weeks before before enrolling the trial, including prescription drugs and over-the-counter drugs;
  19. Blood donation or blood loss ≥200 mL within 3 months before enrolling, or history of using blood products;
  20. Participated any clinical trial within 3 months before enrolling the trial;
  21. 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;
  22. 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;
  23. Person those are directly related to this trial;
  24. Researcher decide, subjects those are non-suitable to participate in this trial.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
58 participants (estimated)

Study arms

  • Experimental
    JX11502MA 0.25mg、0.5mg、1mg、2mg、3mg、6mg、8mg

    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.

    Drug: JX11502MA

  • Placebo comparator
    Placebo 0.25mg、0.5mg、1mg、2mg、3mg、6mg、8mg

    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..

    Drug: Placebo

Interventions

  • DrugJX11502MA

    Oral capsule

  • DrugPlacebo

    Oral capsule

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Day(1)-Day(7)

Secondary outcomes

  1. Cmax

    Maximum Serum Concentration of the parent drug

    Time frame: Day(1)-Day(7)

  2. Tmax

    Time to Reach the Maximum Serum Concentration of the parent drug

    Time frame: Day(1)-Day(7)

  3. AUC

    Area Under the Serum Concentration-Time Curve of the parent drug

    Time frame: Day(1)-Day(7)

  4. t1/2

    Elimination half-life period

    Time frame: Day(1)-Day(7)

07

Study locations

1 of 1 sites recruiting
  • Shanghai Mental Health Center
    Shanghai, China
    • Huafang Li, Doctor · Contact · (86)021-34773128
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 10, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05233657
Lead sponsor
Zhejiang Jingxin Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Feb 10, 2022
Start date
Jan 4, 2020
Primary completion
Jan 31, 2022 (estimated)
Completion
Feb 28, 2022 (estimated)
Last update
Feb 10, 2022

Study contacts

Huafang Li, Doctor
Contact
lhlh_5@163.com
(86)021-34773128

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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