Yabao Pharmaceutical Group
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.
Coronavirus Disease 2019
YBSW015 injection
Early Phase 1
Study Type : | Interventional |
Estimated Enrollment : | 40 participants |
Masking: | Double |
Primary Purpose: | Other |
Official Title: | A Randomized, Double-blind, Placebo-controlled, Dose-escalation Phase Ia Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of YBSW015 Injection in Healthy Subjects |
Actual Study Start Date : | July 2022 |
Estimated Primary Completion Date : | January 2023 |
Estimated Study Completion Date : | February 2023 |
Arm | Intervention/treatment |
---|---|
Experimental: YBSW015 injection 180mg |
Biological: YBSW015 injection |
Experimental: YBSW015 injection 450mg |
Biological: YBSW015 injection |
Experimental: YBSW015 injection 900mg |
Biological: YBSW015 injection |
Experimental: YBSW015 injection 1800mg |
Biological: YBSW015 injection |
Ages Eligible for Study: | 18 Years to 55 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Accepts Healthy Volunteers |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.