Healthy VolunteersPhase 1NCT05656274

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

A Phase 1 study testing JS1-1-01 in people with Healthy Volunteers, run by Tasly Pharmaceutical Group Co., Ltd at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: JS1-1-01
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 48 participants
Where: 1 siteChina
Study dates: 29 Nov 2022to 24 Jul 2023
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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;

Show all 17Show fewer

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
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;
The researchers believe that the subjects have poor compliance or other clinical, social or family factors that are not suitable for inclusion.

Trial locations and contacts

1 site in 1 country.

China1 site

Shanghai Mental Health Center
Shanghai

Other trials in China

About this study

Official title: 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。

Conditions: Healthy Volunteers
Being tested: JS1-1-01, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

JS1-1-01Drug
Oral tables
PlaceboDrug
Oral tables

Study groups in NCT05656274
Study group	Role	What they receive
JS1-1-01	Experimental	JS1-1-01 25mg，50mg，100mg，150mg Receives: Drug: JS1-1-01
Placebo	Placebo comparator	placebo 25mg，50mg，100mg，150mg Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: day 11

Secondary outcomes (19)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Nov 202224 Jul 2023

First posted19 Dec 2022
Study start29 Nov 2022
Primary completion24 Jul 2023
Study completion24 Jul 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy VolunteersStudies of the same condition, open and under way.
More trials run by Tasly Pharmaceutical Group Co., LtdThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05656274
Sponsor's protocol ID: TSL-CM-JS1-1-01-Ⅰb
Status last verified: Nov 2024
First submitted: 9 Dec 2022
Last updated: 19 Nov 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT05656274
Acronym / sponsor ID: TSL-CM-JS1-1-01-Ⅰb
Conditions: Healthy Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: Tasly Pharmaceutical Group Co., LtdIndustry (pharma, biotech, devices)
Study start: 29 Nov 2022 (actual)
Primary completion: 24 Jul 2023 (actual)
Study completion: 24 Jul 2023 (actual)
First posted: 19 Dec 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
JS1-1-01	Experimental	Drug: JS1-1-01JS1-1-01 25mg，50mg，100mg，150mg
Placebo	Placebo comparator	Drug: Placeboplacebo 25mg，50mg，100mg，150mg

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (17 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
JS1-1-01Oral tables	Drug	JS1-1-01
PlaceboOral tables	Drug	Placebo

Primary outcome

Safety and Tolerability
Time frame: day 11
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)

19 secondary outcomes

Pharmacokinetics profile after a single dose
Time frame: day 1
Pharmacokinetics profile after a single dose
Time frame: day 1
Pharmacokinetics profile after a single dose
Time frame: day 1
Pharmacokinetics profile after a single dose
Time frame: day 1
Pharmacokinetics profile after a single dose
Time frame: day 1
Pharmacokinetics profile after a single dose
Time frame: day 1
Pharmacokinetics profile after a single dose
Time frame: day 1
Pharmacokinetics profile after a single dose
Time frame: day 1
Pharmacokinetics profile after multiple dosing.
Time frame: day 11
Pharmacokinetics profile after multiple dosing.
Time frame: day 11
Pharmacokinetics profile after multiple dosing.
Time frame: day 11
Pharmacokinetics profile after multiple dosing.
Time frame: day 11
Pharmacokinetics profile after multiple dosing.
Time frame: day 11
Pharmacokinetics profile after multiple dosing.
Time frame: day 11
Pharmacokinetics profile after multiple dosing.
Time frame: day 11
Pharmacokinetics profile after multiple dosing.
Time frame: day 11
Pharmacokinetics profile after multiple dosing.
Time frame: day 11
Pharmacokinetics profile after multiple dosing.
Time frame: day 11
Pharmacokinetics profile after multiple dosing.
Time frame: day 11

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing JS1-1-01 in people with Healthy Volunteers, run by Tasly Pharmaceutical Group Co., Ltd at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and Tolerability (time frame: day 11). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05656274.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2024.