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
Overview
- Phase
- Phase 1
- Intervention
- JX11502MA
- Conditions
- Schizophrenia
- Sponsor
- Zhejiang Jingxin Pharmaceutical Co., Ltd.
- Enrollment
- 58
- Locations
- 1
- Primary Endpoint
- The incidence rate of adverse reactions
- Last Updated
- 4 years ago
Overview
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.).
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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;
Arms & Interventions
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.
Intervention: JX11502MA
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..
Intervention: Placebo
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Tmax(Day（1）-Day（7）)
- AUC(Day（1）-Day（7）)
- t1/2(Day（1）-Day（7）)
- Cmax(Day（1）-Day（7）)