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RECRUITING
NCT06549959
PHASE1

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

Sponsor: RemeGen Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

248

Start Date

2024-08-05

Completion Date

2024-12-31

Last Updated

2024-08-12

Healthy Volunteers

Yes

Conditions

Interventions

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

Locations (3)

The Affiliated Hospital of Guizhou Medical University

Guiyang, Guizhou, China

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Tianjin People's Hospital

Tianjin, Tianjin Municipality, China