HEC53856 Phase 1 Study - Single and Multiple Oral Dosing in Healthy Volunteers
NCT03886688 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 116
Last updated 2023-04-13
Summary
To evaluate the safety, tolerability and pharmacokinetics of HEC53856 after single or multiple oral administration, as well as the food effect on the pharmacokinetics, in healthy non-elderly subjects.
Conditions
- Healthy
Interventions
- DRUG
-
HEC53856
oral administration
- DRUG
-
oral administration
Sponsors & Collaborators
-
Sunshine Lake Pharma Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Ding Yanhua, Doctor · The First Hospital of Jilin University
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
- 2019-05-14
- Primary Completion
- 2020-01-01
- Completion
- 2020-01-01
Countries
- China
Study Locations
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