drugset / Trial / NCT07466940

A Clinical Study to Evaluate SM17 in Healthy Participants

NCT07466940 ↗

Phase 1 Completed 30 enrolled SinoMab BioScience Ltd
RandomizedSequentialQuadruple-blindTreatment

Summary

This is a phase I study in Chinese healthy adult volunteer participants. It aims to evaluate the safety, tolerability, PK profile and immunogenicity of a single dose of SM17 SC in healthy Chinese adult participants. It also aims to evaluate the bioavailability of SM17 SC compared to SM17 IV.

Timeline

Start
2025-10-14
Primary completion
2026-02-03
Completion
2026-02-03

Drugs

EvaluationDrugModalityDoseRoute
Subject SM17 Monoclonal antibody 195 mg Subcutaneous
Subject SM17 Monoclonal antibody 390 mg Subcutaneous
Subject SM17 Monoclonal antibody 780 mg Subcutaneous