NCT05948059

Safety and Tolerance of Increased Doses of SHR-2106 Injection in Healthy Subjects

A Phase I Clinical Study on Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SHR-2106 After a Single Intravenous or Subcutaneous Administration of SHR-2106 in Healthy Subjects

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 58 (estimated)
• Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, double-blind, placebo-controlled phase I clinical study with the primary objective of evaluating the safety and tolerability of SHR-2106 in healthy subjects after a single intravenous or subcutaneous administration.

Conditions

• Kidney Transplantation

Interventions

Type	Name	Description
DRUG	SHR-2106 injection or placebo	starting dose from 50 mg
DRUG	SHR-2106 injection or placebo	starting dose from 300 mg

Timeline

• Start date: 2023-07-11
• Primary completion: 2024-06-15
• Completion: 2024-06-15
• First posted: 2023-07-17
• Last updated: 2023-11-15

Locations

1 site across 1 country: China