A Study of the Safety,Tolerability,and Pharmacokinetics of Multiple-Ascending Dose JS1-1-01 in Healty Subjects.

A Phase 1b，Randomized, Investigator/Participant-Blind, Placebo-Controlled, Multiple-Ascending Dose Trial to Evaluate the Safety, Tolerance and Pharmacokinetics of JS1-1-01 in Healthy Subjects

The purpose of this study is to evaluate the safety，tolerability，and pharmacokinetics of multiple-accending dose of JS1-1-01。

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: JS1-1-01; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Shanghai Mental Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 41 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Healthy male or female participants 18 to 45 years of age.
2. Body weight ≥ 50 kg ; body mass index of 19 to 28 kg/m^2 ;
3. Subjects have no birth plan and voluntarily take effective contraceptive measures within 3 months after signing the informed consent form and the last medication;
4. Willing and able to sign the informed consent form, and understand and abide by the research procedures.

Exclusion Criteria:

1. Allergic constitution or a history of food and drug allergy;
2. According to the Columbia Suicide Severity Scale (C-SSRS), subjects have suicide risk , or have a history of self mutilation;
3. There are neurological/psychiatric, respiratory, cardiovascular, gastrointestinal, blood and lymphatic, endocrine, skeletal and muscular diseases, liver and kidney dysfunction, or any other diseases and physiological conditions that may affect the study;
4. The results of vital signs, physical examination, electrocardiogram and laboratory examination are abnormal and clinically significant;
5. HBsAg, HCV antibody, HIV antibody or Treponema pallidum specific antibody were positive;
6. Pregnant or lactating women;
7. A History of drug abuse, or positive urine drug abuse screening;
8. Smoking more than 5 cigarettes per day in the last 3 months, or not completely quitting smoking during the study period;
9. In recent three months, the amount of alcohol consumed per week exceeded 14 units of alcohol , or the alcohol breath test was positive, or alcohol consumption was prohibited from 48 hours before the first administration to the end of the test;
10. Those who have taken any drugs within 4 weeks before the first administration (including prescription drugs, over-the-counter drugs, Chinese herbal medicine, vitamins, calcium tablets and other food supplements);
11. Difficulty in blood collection and history of blood sickness and needle sickness;
12. Those who have special requirements on diet and can not follow the unified diet, or are prone to diarrhea, nausea, vomiting, abdominal distension or other gastrointestinal discomfort after drinking milk or dairy products;
13. From 48 hours before the first administration to the end of the study, the subjects refused to stop using any drink or food containing methylxanthine, such as coffee, tea, cola, chocolate, etc;
14. From 7 days before the first administration to the end of the study, the subjects refused to stop using any drink or food containing grapefruit;
15. Participated in any drug clinical trial and took the test drug in recent 3 months; Or those who plan to participate in other clinical trials during the trial
16. Those who have donated blood or lost blood ≥ 200 mL or received blood transfusion or used blood products in recent 3 months; Or those who plan to donate blood during the trial;
17. The researchers believe that the subjects have poor compliance or other clinical, social or family factors that are not suitable for inclusion.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: JS1-1-01; JS1-1-01 25mg，50mg，100mg，150mg	Drug: JS1-1-01; Oral tables
Placebo Comparator: Placebo; placebo 25mg，50mg，100mg，150mg	Drug: Placebo; Oral tables

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and Tolerability	To evaluate the safety and tolerability of JS1-1-01 in healthy participants by assessing the number, severity and type of adverse events, including changes in laboratory safety tests and electrocardiogram (ECG)	day 11

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics profile after a single dose	Cmax of JS1-1-01 and its major metabolites after a single dose.	day 1
Pharmacokinetics profile after a single dose	Tmax of JS1-1-01 and its major metabolites after a single dose.	day 1
Pharmacokinetics profile after a single dose	t1/2 of JS1-1-01 and its major metabolites after a single dose.	day 1
Pharmacokinetics profile after a single dose	AUC0-t of JS1-1-01 and its major metabolites after a single dose.	day 1
Pharmacokinetics profile after a single dose	AUC0-∞ of JS1-1-01 and its major metabolites after a single dose.	day 1
Pharmacokinetics profile after a single dose	λz of JS1-1-01 and its major metabolites after a single dose.	day 1
Pharmacokinetics profile after a single dose	Vd/F of JS1-1-01 and its major metabolites after a single dose.	day 1
Pharmacokinetics profile after a single dose	CL/F of JS1-1-01 and its major metabolites after a single dose.	day 1
Pharmacokinetics profile after multiple dosing.	Css_min of JS1-1-01 and its major metabolites after multiple dosing.	day 11
Pharmacokinetics profile after multiple dosing.	Css_max of JS1-1-01 and its major metabolites after multiple dosing.	day 11
Pharmacokinetics profile after multiple dosing.	Css_av of JS1-1-01 and its major metabolites after multiple dosing.	day 11
Pharmacokinetics profile after multiple dosing.	AUC0-tau of JS1-1-01 and its major metabolites after multiple dosing.	day 11
Pharmacokinetics profile after multiple dosing.	AUC0-∞,ss of JS1-1-01 and its major metabolites after multiple dosing.	day 11
Pharmacokinetics profile after multiple dosing.	AUC0-t,ss of JS1-1-01 and its major metabolites after multiple dosing.	day 11
Pharmacokinetics profile after multiple dosing.	Tmax,ss of JS1-1-01 and its major metabolites after multiple dosing.	day 11
Pharmacokinetics profile after multiple dosing.	T1/2,ss of JS1-1-01 and its major metabolites after multiple dosing.	day 11
Pharmacokinetics profile after multiple dosing.	CLss/F of JS1-1-01 and its major metabolites after multiple dosing.	day 11
Pharmacokinetics profile after multiple dosing.	DF of JS1-1-01 and its major metabolites after multiple dosing.	day 11
Pharmacokinetics profile after multiple dosing.	Rac of JS1-1-01 and its major metabolites after multiple dosing.	day 11

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacodynamics：Concentration of BDNF	Concentration of BDNF(Brain derived neurotrophic factor)	day 9
Pharmacodynamics：Changes in heart rate and blood pressure	Changes in heart rate and blood pressure (systolic/diastolic) compared with baseline	day 9
Pharmacodynamics：Incidence of AESI	Incidence of AESI（adverse event of special interest） (nausea, dry mouth, headache, sweating, somnolence)	day 11

Collaborators and Investigators

• Sponsor: Tasly Pharmaceutical Group Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2022
• Primary Completion (Actual): July 24, 2023
• Study Completion (Actual): July 24, 2023

Study Registration Dates

• First Submitted: December 9, 2022
• First Submitted That Met QC Criteria: December 16, 2022
• First Posted (Actual): December 19, 2022

Study Record Updates

• Last Update Posted (Estimated): November 19, 2024
• Last Update Submitted That Met QC Criteria: November 17, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: TSL-CM-JS1-1-01-Ⅰb

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No