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

NCT05656274 | Completed Phase 1

• 1 other identifier: TSL-CM-JS1-1-01-Ⅰb
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (19)

• Pharmacokinetics profile after a single dose

  day 1

• Pharmacokinetics profile after a single dose

  day 1

• Pharmacokinetics profile after a single dose

  day 1

• Pharmacokinetics profile after a single dose

  day 1

• Pharmacokinetics profile after a single dose

  day 1

Other Outcomes (3)

• Pharmacodynamics：Concentration of BDNF

  day 9

• Pharmacodynamics：Changes in heart rate and blood pressure

  day 9

• Pharmacodynamics：Incidence of AESI

  day 11

Study Arms (2)

JS1-1-01

EXPERIMENTAL

JS1-1-01 25mg，50mg，100mg，150mg

Drug: JS1-1-01

Placebo

PLACEBO COMPARATOR

placebo 25mg，50mg，100mg，150mg

Drug: Placebo

Interventions

JS1-1-01 DRUG

Oral tables

JS1-1-01

Placebo DRUG

Oral tables

Placebo

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

You may not qualify if:

• Allergic constitution or a history of food and drug allergy;
• According to the Columbia Suicide Severity Scale (C-SSRS), subjects have suicide risk , or have a history of self mutilation;
• 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;
• The results of vital signs, physical examination, electrocardiogram and laboratory examination are abnormal and clinically significant;
• HBsAg, HCV antibody, HIV antibody or Treponema pallidum specific antibody were positive;
• Pregnant or lactating women;
• A History of drug abuse, or positive urine drug abuse screening;
• Smoking more than 5 cigarettes per day in the last 3 months, or not completely quitting smoking during the study period;
• 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;
• 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);
• Difficulty in blood collection and history of blood sickness and needle sickness;
• 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;
• 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;
• 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;
• 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

Sponsors & Collaborators

• Tasly Pharmaceutical Group Co., Ltd: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, China

Location

Study Design

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

Study Record Dates

• First Submitted: December 9, 2022
• First Posted: December 19, 2022
• Study Start: November 29, 2022
• Primary Completion: July 24, 2023
• Study Completion: July 24, 2023
• Last Updated: November 19, 2024

Record last verified: 2024-11

Locations

CN (1)