drugset / Trial / NCT05398510
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics Pharmacodynamics of SHR-2010 by Intravenously/Subcutaneously in Healthy Subject
RandomizedParallel-groupDouble-blindTreatment
Summary
The study is being conducted to Evaluate the Safety, Tolerability and Pharmacokinetics pharmacodynamics of SHR-2010 by intravenously/subcutaneously in Healthy Subject.
Timeline
- Start
- 2022-06-30
- Primary completion
- 2023-03-10
- Completion
- 2023-03-10
Publications
- Lin P, Wang C, Hu X, Fang L, Lin H, Sun F, Huang R, Ban R, Feng S, Gao Z, Shen K, Cao Y. Safety, tolerability, pharmacokinetics, and pharmacodynamics of SHR-2010, a novel anti-MASP-2 antibody, in healthy volunteers: a randomized, double-blind, placebo-controlled phase 1 study. Expert Opin Investig Drugs. 2025 Apr;34(4):339-348. doi: 10.1080/13543784.2025.2500291. Epub 2025 May 1.
- Tunnicliffe DJ, Reid S, Craig JC, Samuels JA, Molony DA, Strippoli GF. Non-immunosuppressive treatment for IgA nephropathy. Cochrane Database Syst Rev. 2024 Feb 1;2(2):CD003962. doi: 10.1002/14651858.CD003962.pub3.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SHR-2010 | Unknown | 0.3 mg/kg | Intravenous |
| Subject | SHR-2010 | Unknown | 1.5 mg/kg | Intravenous |
| Subject | SHR-2010 | Unknown | 4 mg/kg | Intravenous |
| Subject | SHR-2010 | Unknown | 8 mg/kg | Intravenous |
| Subject | SHR-2010 | Unknown | 12 mg/kg | Intravenous |