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A Study of HS-10501 Tablets in Healthy Subjects

NCT06359600 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2024-04-11

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety, tolerability, Pharmacokinetics and Pharmacodynamics of single dose and multiple dose of HS-10501 tables in healthy subjects. This is the first clinical study of HS-10501 tables. This study has 2 parts. Parts A involve a single dose of HS-10501 tables or placebo and will last about 8 days. Also, this part will also further explore the food effect. Parts B involve multiple doses of HS-10501 tables or placebo and will last about 4 weeks.

Conditions

  • Healthy Subjects

Interventions

DRUG

HS-10501 tablet

Administered orally

DRUG

Placebo

Administered orally

Sponsors & Collaborators

  • Jiangsu Hansoh Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2024-03-14
Primary Completion
2025-01-31
Completion
2025-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT06359600 on ClinicalTrials.gov