NCT06549959

A Single Dose Study to Investigate the Pharmacokinetics (PK) of Telitacicept Pre-filled Injection and Freeze-dried Powder Injection in Chinese Healthy Subjects

An Open-label, Randomized, Parallel Group, Single Dose Study to Investigate the Pharmacokinetics of Telitacicept Pre-filled Injection and Freeze-dried Powder Injection in Chinese Healthy Subjects

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 248 (estimated)
• Sponsor: RemeGen Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This is an open-label, randomized, parallel group, single dose study in healthy Chinese subjects. The purpose of this study is to evaluate the Pharmacokinetics and safety of Telitacicept Pre-filled Injection and Freeze-dried powder Injection.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Telitacicept Pre-filled Injection 80mg	The patient received one treatment of Telitacicept 80mg in the test group
DRUG	Telitacicept Freeze-dried powder Injection 80mg	The patient received one treatment of Telitacicept 80mg in the test group

Timeline

• Start date: 2024-08-05
• Primary completion: 2024-11-30
• Completion: 2024-12-31
• First posted: 2024-08-12
• Last updated: 2024-08-12

Locations

3 sites across 1 country: China