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
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: t
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• Healthy male and female subjects must be at least 18 years old and no more than 55 years old on the date of signing the ICF.
• The female subjects must be non-pregnant or non-childbearing potential.
• Subjects must understand the study procedures and methods, voluntarily participate in this study and sign the ICF in person.
Locations
Other Locations
China
Guangdong Provincial People's Hospital
RECRUITING
Guangzhou
Contact Information
Primary
Ying Wang
ying.wang.yw30@hengrui.com
+86-15052585832
Time Frame
Start Date: 2025-03-18
Estimated Completion Date: 2025-08
Participants
Target number of participants: 82
Treatments
Experimental: HRS-1301 group
Placebo_comparator: HRS-1301 placebo group
Related Therapeutic Areas
Sponsors
Leads: Shandong Suncadia Medicine Co., Ltd.