drugset / Trial / NCT05369754
A Phase Ia Clinical Study to Evaluate the Safety, Tolerability, PK and Immunogenicity of YBSW015 in Healthy Subjects
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | YBSW015 | Unknown | 180 mg | Intravenous |
| Subject | YBSW015 | Unknown | 450 mg | Intravenous |
| Subject | YBSW015 | Unknown | 900 mg | Intravenous |
| Subject | YBSW015 | Unknown | 1800 mg | Intravenous |