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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| YBSW015 injection 180mg | Experimental |
| |
| YBSW015 injection 450mg | Experimental |
| |
| YBSW015 injection 900mg | Experimental |
| |
| YBSW015 injection 1800mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YBSW015 injection | Biological | Prepared YBSW015 injection is intravenously injected by an infusion pump or gravity infusion with intravenous infusion of 250 mL for 60 min±10 min. |
| Measure | Description | Time Frame |
|---|---|---|
| safety of YBSW015 injection | Evaluation of treatment-emergent adverse event (TEAE) and serious adverse events (SAE) during treatment; | from screening visit to the end of the follow-up period, assessed up to 85 days |
| tolerability of YBSW015 injection | Evaluation of local tolerance: administration site reaction; | from screening visit to the end of the follow-up period, assessed up to 85 days |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameter | Peak concentration (Cmax) Immunogenicity: To detect the positive rate and titer of anti-drug antibody ADA | from screening visit to the end of follow-up period, assessed up to 85 days |
| PK parameter |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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peak time (Tmax)
| from screening visit to the end of follow-up period, assessed up to 85 days |
| PK parameter | terminal elimination rate constant (λz) | from screening visit to the end of follow-up period, assessed up to 85 days |
| PK parameter | terminal elimination half-life (t1/2) | from screening visit to the end of follow-up period, assessed up to 85 days |
| PK parameter | area under the curve from time zero to the time of the last time of quantifiable concentration (AUC0-t) | from screening visit to the end of follow-up period, assessed up to 85 days |
| PK parameter | area under the concentration-time curve from time zero to infinite time (AUC0-∞) | from screening visit to the end of follow-up period, assessed up to 85 days |
| PK parameter | extrapolated percentage of AUC0-∞ (%AUCex) | from screening visit to the end of follow-up period, assessed up to 85 days |
| PK parameter | apparent clearance (CLz) | from screening visit to the end of follow-up period, assessed up to 85 days |
| PK parameter | apparent volume of distribution (Vz) | from screening visit to the end of follow-up period, assessed up to 85 days |
| PK parameter | mean residence time (MRT) | from screening visit to the end of follow-up period, assessed up to 85 days |
| Immunogenicity | positive rate of anti-drug antibody ADA | from screening visit to the end of follow-up period, assessed up to 85 days |
| Immunogenicity | Titer of anti-drug antibody ADA | from screening visit to the end of follow-up period, assessed up to 85 days |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |