A Phase 1 Study of Single and Multiple Intravenous Doses of SM17 in Healthy Subjects

Summary

This trial is a phase 1, first-in-human, randomized, double-blind, placebo-controlled dose escalation trial following single and multiple doses intravenous administration of SM17. It aims to evaluate the safety, tolerability, pharmacokinetic characteristics, pharmacodynamic effect and immunogenicity of single and multiple doses of SM17 injection in healthy subjects.

Timeline

Start

2022-06-14

Primary completion

2023-09-26

Completion

2023-09-26

Publications

• Xu G, Paglialunga S, Qian X, Ding R, Webster K, van Haarst A, Engel C, Hui CW, Lam LH, Li W, Wu WC, Rasmussen S, Hunt A, Leung SO. Evaluation of the safety, tolerability, pharmacokinetics and pharmacodynamics of SM17 in healthy volunteers: results from pre-clinical models and a first-in-human, randomized, double blinded clinical trial. Front Immunol. 2024 Dec 9;15:1495540. doi: 10.3389/fimmu.2024.1495540. eCollection 2024.

Drugs

Indications