A Safety，Tolerability and Pharmacokinetics Clinical Trial of JX11502MA Capsule

NCT05233657 | Unknown Phase 1

• 1 other identifier: JX11502MA-I-01
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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.).

Conditions

Schizophrenia

Outcome Measures

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

  Day（1）-Day（7）

Secondary Outcomes (4)

• Cmax

  Day（1）-Day（7）

• Tmax

  Day（1）-Day（7）

• AUC

  Day（1）-Day（7）

• t1/2

  Day（1）-Day（7）

Study Arms (2)

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.

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..

Drug: Placebo

Interventions

JX11502MA DRUG

Oral capsule

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

Placebo DRUG

Oral capsule

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

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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) .

Sponsors & Collaborators

• Zhejiang Jingxin Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 38054696 DERIVED

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Central Study Contacts

Huafang Li, Doctor

CONTACT

（86）021-34773128; lhlh_5@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2021
• First Posted: February 10, 2022
• Study Start: January 4, 2020
• Primary Completion: January 31, 2022
• Study Completion: February 28, 2022
• Last Updated: February 10, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)