NCT05701826

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS3797 in Healthy Subjects

Dose Escalation Study on the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS3797 After Intravenous Infusion Administration in Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a single-center, open-label, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS3797 in Chinese adults. To evaluate the effect of IV infusion duration on the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS3797. To explore the ED95 dosage of HRS3797 in Chinese adults.

Conditions

• Skeletal Muscle Relaxation

Interventions

Type	Name	Description
DRUG	HRS3797	HRS3797 for injection, low dose
DRUG	HRS3797	HRS3797 for injection, medium dose
DRUG	HRS3797	HRS3797 for injection, high dose

Timeline

• Start date: 2023-02-15
• Primary completion: 2023-06-02
• Completion: 2023-06-02
• First posted: 2023-01-27
• Last updated: 2023-06-07

Locations

1 site across 1 country: China