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

NCT06549959 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 248

Last updated 2024-08-12

No results posted yet for this study

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

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

Sponsors & Collaborators

  • RemeGen Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-08-05
Primary Completion
2024-11-30
Completion
2024-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06549959 on ClinicalTrials.gov