A Trial of HS-10511 in Healthy Subjects
NCT06210607 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 96
Last updated 2024-01-18
Summary
This study is a phase I, randomized, double-blind, placebo-controlled clinical trial evaluating the safety, tolerability, and pharmacodynamic (PK) and pharmacodynamic (PD) characteristics of HS-10511 when administered as single oral dose and multiple oral doses in healthy adult subjects.
Conditions
Interventions
- DRUG
-
HS-10511 Tablets
HS-10511 tablets for 5\~6 SAD cohorts and 4 MAD cohorts
- DRUG
-
HS-10511 Tablets Placebo
HS-10511 tablets placebo for 5\~6 SAD cohorts and 4 MAD cohorts
Sponsors & Collaborators
-
Jiangsu Hansoh Pharmaceutical Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-01-31
- Primary Completion
- 2024-06-30
- Completion
- 2024-12-31
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