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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
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.
Details
| Lead sponsor | Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | NOT_YET_RECRUITING |
| Enrolment | 180 |
| Start date | 2025-07 |
| Completion | 2026-01 |
Conditions
- Atopic Dermatitis
Interventions
- new formulations of 611
- existing formulations of 611
Primary outcomes
- Cmax — 57 days
- AUC — 57 days
Countries
China