PK/PD Study of YZJ-1139

Shanghai Haiyan Pharmaceutical Technology

Status and phase: Completed; Phase 1

Conditions: Insomnia

Treatments: Drug: YZJ-1139; Drug: Zolpidem; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06685341

YZJ-1139-1-02

Details and patient eligibility

About

Primary Objective： To determine the dose-response relationship of YZJ-1139 in young and elderly Chinese subjects after a single oral administration of different doses, and to compare it with zolpidem at clinical doses.

Secondary Objective: To investigate the safety and tolerability of YZJ-1139 in young and elderly Chinese subjects after a single oral administration of different doses, and to compare it with zolpidem at clinical doses.

Enrollment: 20 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Young adults and elderly Chinese healthy subjects, both male and female;
2. Age: [young adult group] 18-45 years old (including the threshold value); [Elderly group]65~75 years old (including the cut-off value);
3. Body weight [only for young adults]: ≥50kg, BMI: 18~28kg/m2 (including the threshold value);
4. Understand and sign the informed consent to participate in the study.

Exclusion criteria

1. History of heart, liver, lung, kidney, digestive tract, blood system, neuropsychiatric system and other diseases, including anxiety and depression, that researchers deem clinically significant;
2. Comprehensive physical examination, neurological examination, laboratory examination, ECG examination, etc. indicate that the subject has abnormalities that are judged by the researcher as clinically significant;
3. Poor compliance with the pharmacodynamics training before administration;
4. Have taken any medication in the two weeks prior to study administration, and the investigator judges it may affect the evaluation results;
5. History of food and drug allergy or allergic reaction that the researcher determines to be clinically significant;
6. Serological examination (HBsAg, anti-HCV, anti-HIV, TP-Ab) with positive results;
7. History of alcohol or drug abuse within the year prior to study administration that the investigators believe may have affected the results assessed in this study;
8. Frequent (> 1 time per month) use of hypnotic drugs, and screening and baseline benzodiazepine urine screening positive;
9. Participants who need to work night shifts, stay up late, or stay at least 3 time zones away from the study site within 2 weeks before and during the study;
10. Subjects who could not maintain a regular sleep and rest schedule (get up at 6-8 am and go to sleep at 10-12 PM) within 1 week before and during the study and who were judged by the investigator to be likely to affect the results of this study;
11. Those who could not quit smoking and alcohol drinking as required during the study period or whose carbon monoxide breath test detected >7 ppm during the screening period (further confirmation by urine cotinine test if deemed necessary by the investigators);
12. Participants who have participated in any drug clinical trial as a subject within 3 months prior to study administration;
13. Patients who donated blood or blood products ≥400 mL or 2 units within three months prior to drug administration;
14. Those who do not agree to avoid the use of tobacco, alcohol or caffeinated beverages, or to avoid strenuous exercise, or to avoid other factors affecting the absorption, distribution, metabolism or excretion of drugs within 24 hours before and during the trial;
15. Don't agree or is unable to refrain from eating grapefruit or other related tropical fruits and beverages and from using St. John's Wort during the 24 hours prior to the first dose and during the study period;
16. Women who are pregnant or nursing, or who test positive for serum HCG before trial administration, or who cannot/do not use investigator-approved contraception during the study as required;
17. Those with abnormal cognitive function assessment (MMSE less than 26 points) and judged by the researchers to be clinically significant;
18. Subjects deemed unsuitable for this clinical study by the investigator.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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20 participants in 4 patient groups, including a placebo group

Drug: YZJ-1139 high dose group

Experimental group

Description:

Subjects will be into two groups：Young adult subjects and elderly subjects

Treatment:

Drug: YZJ-1139

Drug: YZJ-1139 low dose group

Experimental group

Description:

Subjects will be into two groups：Young adult subjects and elderly subjects

Treatment:

Drug: YZJ-1139

Drug: Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: Zolpidem

Active Comparator group

Treatment:

Drug: Zolpidem