Safety and Tolerance of Increased Doses of HRS-1780 Tablets in Healthy Subjects
NCT05638126 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 96
Last updated 2023-10-25
Summary
This is a randomized, double-blind, placebo-controlled phase I clinical study. The primary objective is to evaluate the safety, tolerability, PK, and PD of single- and multiple-dose HRS-1780 in healthy subjects, and to evaluate the food effect on PK of HRS-1780.
Conditions
Interventions
- DRUG
-
HRS-1780 table or placebo
HRS-1780 table or placebo single dose
- DRUG
-
HRS-1780 table or placebo
HRS-1780 table or placebo single dose with food effect
- DRUG
-
HRS-1780 table or placebo
HRS-1780 table or placebo multiple dose
Sponsors & Collaborators
-
Shandong Suncadia Medicine Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-02-02
- Primary Completion
- 2023-12-31
- Completion
- 2023-12-31
Countries
- China
Study Locations
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