NCT05369767

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Single-dose Injection of SHR-2004 in Healthy Subjects

A Phase 1, Randomized, Double Blind, Dose-escalation, Placebo Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SHR-2004 in Healthy Subjects

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Beijing Suncadia Pharmaceuticals Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this study is to assess the safety and tolerability of SHR-2004 injection in healthy subjects. In addition, this study will provide information on pharmacokinetics and pharmacodynamics of SHR-2004 injection in healthy subjects.

Conditions

• Prevention of Arterial and Venous Thrombosis

Interventions

Type	Name	Description
DRUG	SAD, SHR-2004	Ascending dose
DRUG	SAD, SHR-2004 placebo	Ascending dose

Timeline

• Start date: 2022-05-24
• Primary completion: 2023-01-30
• Completion: 2023-01-30
• First posted: 2022-05-11
• Last updated: 2022-11-30

Locations

1 site across 1 country: China