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The Phase I Study of HS-10509 in Chinese Adult Subjects

A Multicenter, Randomized, Placebo-Controlled, Double-Blinded Phase Ⅰ Study to Evaluate the Tolerability and Pharmacokinetics of HS-10509 in Chinese Adult Subjects

NCT06301074•Jiangsu Hansoh Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

The study is to evaluate the safety, tolerability, and PK characteristics following single administration of HS-10509 in healthy adults, and multiple administrations of HS-10509 in patients with schizophrenia. Participants will have HS-10509 tablets or placebo once in the single ascending dose (SAD) part or once daily for 28 days in the multiple ascending dose (MAD) part.

Detailed Description

This is a first-in-human, randomized, double-blinded, and placebo-controlled study. In the single-ascending dose (SAD) part, subjects will receive HS-10509 tablets or placebo once. There are 5 predefined dose cohorts of 10 subjects each (including 8 for HS-10509 and 2 for placebo). SAD part of the study will assess the safety, tolerability, and PK characteristics of single ascending doses of HS-10509 to determine the dose range that is safe and well tolerated in healthy subjects. In the multiple ascending dose (MAD) part, patients with schizophrenia will receive HS-10509 or placebo once daily for continously 28 days. There are 3 predefined dose cohorts with 10 subjects each (including eight for HS-10509 and 2 for placebo). MAD of the study will assess the safety, tolerability, PK and primary efficacy of multiple ascending doses of HS-10509 in subjects with schizophrenia.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Part 1(SAD) for healthy adults
•1. When signing the ICF, the subject should be between 18 and 45 years old (inclusive);
•2. Have a full understanding of the trial content, process and possible adverse reactions, be willing and able to abide by the contraindications or restrictions stipulated in this program, and voluntarily sign the ICF;
•3. Male weight ≥50kg, female weight ≥45kg, body mass index (BMI= weight/height 2\[kg/m2\]) in the range of 18-28 (inclusive);
•4. Agree to use (or have their partner use) an effective contraceptive method from the date of signing the ICF until 90 days after the last dose, and there are no plans to donate eggs/sperm.
•Part 2 (MAD) for Schizophrenia patients
•1. When signing the ICF, the subject is between 18 and 65 years old (inclusive);
•2. BMI at screening and baseline was between 18.5 and 30.0 kg/m2 (inclusive), and male subjects were ≥50 kg and female subjects were ≥45 kg;
•3. Meet the diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) (DSM-5) diagnostic criteria for schizophrenia;
•4. The total score of PANSS during screening and baseline was ≤90 points;
+5 more criteria

Exclusion Criteria

•Part 1 (SAD) for healthy adults
•1. Other clinically significant diseases;
•2. After C-SSRS assessment, answer "yes" to question 4 or question 5 of the suicidal ideation questionnaire within 1 year, or have a history of suicidal behavior;
•3. allergies to multiple food or drug allergies, or known allergies to test drug ingredients;
•4. Within 2 weeks before the trial (or 5 half-lives of the drug, whichever is longer) or plan to take any medication during the trial, including prescription and over-the-counter drugs, Chinese herbal medicines, but not including vitamins, dietary supplements;
•5. Drug abusers or those who have used soft drugs (e.g., marijuana) within 3 months prior to the trial, or hard drugs (e.g., cocaine, PCP, etc.) within 1 year prior to the trial;
•6. Have a history of alcoholism or consume more than 14 units of alcohol per week in the last 2 weeks (1 unit = 285 mL for beer, 25 mL for spirits, 150 mL for wine);
•7. Smokers who smoked more than 5 cigarettes per day in the 3 months before the test, or could not stop using any tobacco products during the test;
•8. Blood donation or significant blood loss within 3 months before the first dose of the trial drug (≥450mL within 30 days, excluding blood collection at the screening stage), or a blood donation plan during the study period or within 3 months after the last visit;
•9. Those who had undergone surgery within 3 months prior to screening, or planned to undergo surgery during the study period; Or have undergone medical or surgical treatments that permanently alter the absorption, distribution, metabolism, and excretion of oral drugs (such as gastric or intestinal surgery);
+29 more criteria

Locations (1)

The First Hospital of Jilin University

Changchun, Jilin, China

Key Dates

Start Date

March 1, 2024

Primary Completion Date

May 1, 2024

Completion Date

October 1, 2024

Last Updated

March 8, 2024

Enrollment

ESTIMATED participants

Conditions

Schizophrenia

Interventions

HS-10509

DRUG

Placebo

DRUG

Contacts

Lei Sun

CONTACT

+86 18652107831 sunl6@hspharm.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 8, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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The Phase I Study of HS-10509 in Chinese Adult Subjects

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Exclusion Criteria

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