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.
Study ID
NCT06549959
Phase
PHASE1
Status
Recruiting
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Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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.

Key Dates

Start date
Aug 5, 2024
Status verified
Aug 2024
Primary completion
Nov 30, 2024
Completion
Dec 31, 2024

Study Design

Enrollment
248 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Telitacicept Pre-filled Injection 80mg
  • Experimental: Telitacicept Freeze-dried powder Injection 80mg

Primary Outcome Measure

C-max [ Time Frame: Day 0#Day 1#Day 2#Day 3#Day 5#Day 8#Day 15#Day 22#Day 29#Day 43#Day 57 ]

Central Contacts

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