Depressive symptoms, dissociative symptoms
Conditions
Interventions
42mg dose group-placebo group:Placebo
84mg dose group-experimental group:(R) ketamine hydrochloride nasal spray
84mg dose group-placebo group:Placebo
126mg dose group-experimental group:(R) ketamine hydrochloride nasal spray
126mg dose group-placebo group:Placebo
182mg dose group-experimental group:(R) ketamine hydrochloride nasal spray
182mg dose group-placebo group:Placebo
42mg dose group-experimental group:(R) ketamine hydrochloride nasal spray
Sponsors
Beijing An Ding Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Healthy male/female volunteers who are at least 18 years old and not more than 45 years old (inclusive) at the time of signing the informed consent form; 2. The body mass index (BMI) at screening should be between 18.5~28.0 kg/m^2 (including the end value), and the weight of male volunteers should not be less than 50kg, and the weight of female volunteers should not be less than 45 kg; 3. Those who voluntarily participate in and sign the informed consent form after understanding the purpose, content, process and possible risks of the trial; 4. Able to communicate well with the investigator, willing and able to comply with the lifestyle restrictions specified in the protocol, and cooperate with the completion of the trial process.
Exclusion criteria
Exclusion criteria: 1.Subjects who, in the opinion of the investigator, are unsuitable for nasal spray administration (including but not limited to structural abnormalities of the nasal cavity, ulcers visible to the naked eye in the nasal cavity, etc.); 2.The investigator determines that the subject's current and past medical history has a disease or dysfunction that affects the clinical trial, including but not limited to diseases of the central nervous system, cardiovascular system, respiratory system, gastrointestinal system, urinary system, endocrine system, hematological system, and so on; 3.Currently or previously suffering from mental disorders and brain dysfunction; 4.The existence of any disease or surgical condition that may significantly affect the absorption, distribution, metabolism and excretion of drugs, or any disease or surgical condition that may pose a hazard to the subjects participating in the trial; such as chronic allergic rhinitis history, history of gastrointestinal surgery (gastrectomy, gastrointestinal anastomosis, intestinal resection, etc.), urinary tract obstruction or urinary tract difficulties, gastroenteritis, peptic ulcers, history of gastrointestinal bleeding; and so on; 5.Any drugs that inhibit or induce liver enzymes (e.g., inducers such as phenobarbital, rifampicin, carbamazepine, phenytoin, dexamethasone, etc.; inhibitors such as fluvoxamine, S-mefenotoxin, propofol, isoniazid, phenothiazine, etc.) within 1 month prior to screening; 6.Those who have taken any medication, both prescription and over-the-counter, within 2 weeks prior to screening; 7.Known hypersensitivity to any of the components of the test drug, allergy (two or more drugs and food allergies); 8.Abnormal vital signs, laboratory and ECG tests that are clinically significant in the judgment of the investigator (e.g., QTc >450 ms in men, QTc >470 ms in women, Friericia correction); 9.Hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), HIV antibody (HIV-Ab), and Treponema pallidum antibody (TP-Ab) are not negative; 10.A history of alcohol abuse (i.e., more than 14 standard units of alcohol per week [1 unit = 360mL of beer or 45mL of 40% alcohol by volume spirits or 150mL of wine]) or a positive breath test for alcohol within 1 year prior to screening; 11.Smoking = 5 cigarettes per day on average in the 3 months prior to screening or a positive smoke test; 12.Those who have a history of drug or substance abuse within 1 year prior to screening, or those who have a positive urine drug screen; 13.Pregnant and lactating women; and those who refused to use effective non-pharmacological contraception (e.g., abstinence, intrauterine device) for the entire study period and for 3 months after the end of the study, or those who had a sperm or egg donation program; or had a positive blood/urine pregnancy test; 14.Participated in any clinical trial within 3 months prior to the administration of the drug; 15.Have special dietary requirements and are unable to follow a standardized diet; 16.Have donated blood (including component blood donations) or lost a large amount of blood (greater than or equal to 200mL) within 3 months prior to screening; have received a blood transfusion or used blood products; 17.Those who have a history of surgery within 3 months prior to dosing, or have not recovered from surgery, or have an anticipated surgical procedure planned during the trial; 18.Persons directly related to the clinical trial; 19.Subjects w
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cerebral blood flow perfusion;Brain structure;Peripheral blood RNA expression;Brain functional activity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Depressive symptoms;Routine blood results;Anxiety symptoms;Anhedonia symptoms;Alertness/sedation;Detached state;Urinalysis results;Blood biochemical results;Coagulation function; | — |
Countries
China
Contacts
Public ContactYang Zhi
Beijing An Ding Hospital, Capital Medical University
Outcome results
None listed