Study of Bioavailability, Pharmacodynamics and Safety of SHR-1209 Administered by Single Subcutaneous Injection at Different Sites in Healthy Volunteers

Summary

In order to meet the preferences and needs of different patients for injection sites and improve the medication compliance of patients, it is planned to compare the bioavailability, pharmacokinetics, pharmacodynamic and safety data to assess feasibility of multiple injection sites for administration.

Timeline

Start

2022-05-25

Primary completion

2022-12-31

Completion

2022-12-31

Outcome

Met primary endpoint

paper The geometric mean ratios of maximum serum concentration (Cmax), area under the serum concentration versus time curve (AUC) from time zero to the time of last quantifiable concentration (AUC0-last), and AUC from time zero extrapolated to infinity (AUC0-inf) between groups were all close to 1, with two-sided 90% confidence intervals within 0.8-1.25. PMID 40252193 ↗

Publications

• Shu C, Wang Y, Feng S, Yang S, Shen K. Population Pharmacokinetics and Pharmacodynamics Modeling for the Use of Recaticimab in Healthy Volunteers and Patients with Hypercholesterolemia. Clin Pharmacokinet. 2025 Sep;64(9):1341-1355. doi: 10.1007/s40262-025-01512-5. Epub 2025 Jun 30.
• Wang Y, Cheng Y, Guo Y, Fan Y, Zhou R, Zhang Q, Xu Y, Feng S, Shen K, Hu W. A Phase I Study to Evaluate the Relative Bioavailability, Pharmacodynamics, and Safety of a Single Subcutaneous Injection of Recaticimab at Three Different Sites in Healthy Chinese Subjects. Eur J Drug Metab Pharmacokinet. 2025 May;50(3):265-272. doi: 10.1007/s13318-025-00944-5. Epub 2025 Apr 19.

Drugs

Indications