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

Recruiting Phase 1 Interventional Study
Healthy
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
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At a Glance
Age
18 – 50
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
248 (estimated)
Sponsor
RemeGen Co., Ltd. · Industry
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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. 18-50 years old at the time of signing the informed consent form,gender is unlimited; 2. Male Weight 55-70 kg, female Weight 50-65 kg, and BMI ranging from 18 to 28 kg/m2 (including critical values); 3. Physical examination, vital signs, chest radiographs, ECG, epidemiologic …
Contacts

Binghua Xiao

86-010-58076833

binghua.xiao@remegen.com

CONTACT