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

NCT06301074 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-03-08

No results posted yet for this study

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.

Conditions

Interventions

DRUG

HS-10509

In SAD, participants will be assigned to receive either HS-10509 or a matching placebo for a single administration. There are 5 predefined dose cohorts (each cohort including 8 for HS-10509 and 2 for placebo), initially starting at 10 mg for cohort 1. In MAD, participants will assigned to receive HS-10509 or a matching placebo once daily for 28 days. There will be 3 dose cohorts (each cohort including 8 for HS-10509 and 2 for placebo), and the dose for each cohort is to be determined.

DRUG

Placebo

In SAD, participants will be assigned to receive either HS-10509 or a matching placebo for a single administration. There are 5 predefined dose cohorts (each cohort including 8 for HS-10509 and 2 for placebo), initially starting at 10 mg for cohort 1. In MAD, participants will assigned to receive HS-10509 or a matching placebo once daily for 28 days. There will be 3 dose cohorts (each cohort including 8 for HS-10509 and 2 for placebo), and the dose for each cohort is to be determined.

Sponsors & Collaborators

  • Jiangsu Hansoh Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Xiaojiao Li, Dr. · The First Hospital of Jilin University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-03-31
Primary Completion
2024-05-31
Completion
2024-10-31

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06301074 on ClinicalTrials.gov