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A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS-1301 in Healthy Subjects
Sponsor: Shandong Suncadia Medicine Co., Ltd.
Summary
This study aims to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS-1301 following single and multiple dose administration in healthy subjects. The study consists of two parts (Part 1 and Part 2) with 82 subjects planned to be enrolled. Possible adjustments to sample size, treatment duration and follow-up time will depend upon emerging data.
Official title: A Phase I, Randomized, Double-blind and Dose-escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS-1301 Following Single and Multiple Dose Administration in Healthy
Key Details
Gender
All
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
84
Start Date
2025-03-18
Completion Date
2025-08-12
Last Updated
2026-09-30
Healthy Volunteers
Yes
Conditions
Interventions
HRS-1301
HRS-1301.
HRS-1301 placebo
HRS-1301 placebo.
Locations (1)
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China