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NOT YET RECRUITING
NCT07042113
PHASE1

A Study of Two Different Formulations of 611 in Healthy Adult Subjects in China

Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

View on ClinicalTrials.gov

Summary

The main purpose of this study is to compare two different formulations (mixtures) of 611 in healthy participants. This study will compare how much of each formulation gets into the blood stream.

Official title: A Randomized, Open-label, Parallel-enrollment Pharmacokinetic Comparison Study of Two Formulations of Recombinant Anti-IL-4Rα Humanized Monoclonal Antibody Injection (611) Injected Subcutaneously in Healthy Adult Subjects in China

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

180

Start Date

2025-07

Completion Date

2026-01

Last Updated

2025-06-27

Healthy Volunteers

Yes

Interventions

DRUG

new formulations of 611

Subjects will receive new formulations of 611 300mg once subcutaneous injection on D1

DRUG

existing formulations of 611

Subjects will receive existing formulations of 611 300mg once subcutaneous injection on D1

Locations (2)

The Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiangsheng, China

Shanghai General Hospital

Shanghai, China