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A Study of HS-10501 Tablets in Healthy Subjects - Trial NCT06359600

Access comprehensive clinical trial information for NCT06359600 through Pure Global AI's free database. This Phase 1 trial is sponsored by Jiangsu Hansoh Pharmaceutical Co., Ltd. and is currently Recruiting. The study focuses on Healthy Subjects. Target enrollment is 84 participants.

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NCT06359600
Phase 1
Recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06359600
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A Study of HS-10501 Tablets in Healthy Subjects
A Randomized, Double-blind, Placebo-controlled, Dose Escalation Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HS-10501 Tablets After Single and Multiple Oral Doses in Healthy Subjects

Study Focus

Healthy Subjects

HS-10501 tablet

Interventional

drug

Sponsor & Location

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Hefei, China

Timeline & Enrollment

Phase 1

Mar 14, 2024

Jun 30, 2025

84 participants

Primary Outcome

Incidence and severity of adverse events(AE) , serious AEs and AE leading to withdrawal from treatment.,Number of participants with clinically significant abnormalities in lab tests,Number of participants with clinically significant change from baseline in vital signs,Change from baseline in Electrocardiogram (ECG)

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.

ICD-10 Classifications

Occupational health examination
Seeking and accepting physical, nutritional and chemical interventions known to be hazardous and harmful
Routine child health examination
Examination and observation for other reasons

Data Source

ClinicalTrials.gov

NCT06359600

Non-Device Trial