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COMPLETED
NCT06857253
PHASE1

A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS-1301 in Healthy Subjects

Sponsor: Shandong Suncadia Medicine Co., Ltd.

View on ClinicalTrials.gov

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

DRUG

HRS-1301

HRS-1301.

DRUG

HRS-1301 placebo

HRS-1301 placebo.

Locations (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China