NCT06684041

A Safety, Tolerability, Pharmacokinetic/Pharmacodynamic Study, and QT Interval Study of HRS-5965 Capsules in Healthy Subjects

Safety, Tolerability, Pharmacokinetic/Pharmacodynamic Study of Multiple Doses of HRS-5965 Capsules in Healthy Subjects and a Phase I Clinical Trial of the Effect of HRS-5965 on QT Interval in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Chengdu Suncadia Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This was a randomized, double-blind, single-dose, placebo-controlled phase I clinical trial. This study plans to conduct three dose groups of dose 1, dose 2, and dose 3. A total of 32 healthy subjects were planned to be enrolled.

Conditions

• Hemolytic Anemia

Interventions

Type	Name	Description
DRUG	HRS-5965 capsule	HRS-5965 capsule
DRUG	HRS-5965 capsule placebo	HRS-5965 capsule placebo

Timeline

• Start date: 2024-11-09
• Primary completion: 2025-04-07
• Completion: 2025-04-07
• First posted: 2024-11-12
• Last updated: 2025-07-04

Locations

1 site across 1 country: China