NCT07042113

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

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

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

This study is a randomized, open-label, parallel-designed comparative pharmacokinetic study to evaluate the biosimilarity between the formulations of 611.A total of about 180 healthy adult subjects in China were planned to be included, and the qualified subjects were randomly stratified according to the research center, body weight (≥65kg, \<65kg), and randomly assigned to the test preparation group and the reference preparation group at a ratio of 1:1, and received a single subcutaneous injection of 300 mg of the experimental drug according to their group. Blood was collected on D1 and D2, D3, D4, D5, D6, D7, D8, D15, D22, D29, D43 and D57 after administration, respectively.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-07-01
• Primary completion: 2026-01-01
• Completion: 2026-01-01
• First posted: 2025-06-27
• Last updated: 2025-06-27

Locations

2 sites across 1 country: China