drugset / Trial / NCT05369754

A Phase Ia Clinical Study to Evaluate the Safety, Tolerability, PK and Immunogenicity of YBSW015 in Healthy Subjects

NCT05369754 ↗

Phase 0 Unknown 40 enrolled Yabao Pharmaceutical Group
RandomizedSequentialDouble-blindOther

Summary

This is phase Ia study to research YBSW015 injection which is a monomolecular bispecific antibody. The Primary objective is to evaluate the safety and tolerability of YBSW015 injection after a single intravenous injection at different doses in healthy subjects. The Secondary objective is to evaluate the pharmacokinetic characteristics and immunogenicity of different doses of YBSW015 injection after a single intravenous injection in healthy subjects. This study is a single-center, randomized, double-blind, placebo-controlled, single-dose escalation clinical trial.

Timeline

Start
2022-07
Primary completion
2023-01
Completion
2023-02

Drugs

EvaluationDrugModalityDoseRoute
Subject YBSW015 Unknown 180 mg Intravenous
Subject YBSW015 Unknown 450 mg Intravenous
Subject YBSW015 Unknown 900 mg Intravenous
Subject YBSW015 Unknown 1800 mg Intravenous

Indications