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This is a single-center, double-blind, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR-3032 in healthy adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A | Experimental | SHR-3032 |
|
| Treatment group B | Placebo Comparator | SHR-3032 Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-3032 | Drug | Single dose at varying dosage levels depending on treatment assignment |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence and severity of adverse events/serious adverse events | From ICF signing date to day 99 | |
| Pharmacokinetic parameter of SHR-3032: Cmax | 0 minute to day 99 after administration | |
| Pharmacokinetic parameter of SHR-3032: AUC0-t | 0 minute to day 99 after administration | |
| Pharmacokinetic parameter of SHR-3032: AUC0-∞ | 0 minute to day 99 after administration | |
| Pharmacokinetic parameter of SHR-3032: Tmax | 0 minute to day 99 after administration | |
| Pharmacokinetic parameter of SHR-3032: t1/2 | 0 minute to day 99 after administration | |
| Pharmacokinetic parameter of SHR-3032: CL | 0 minute to day 99 after administration | |
| Pharmacokinetic parameter of SHR-3032: Vss | 0 minute to day 99 after administration |
| Measure | Description | Time Frame |
|---|---|---|
| The percentage of target receptor occupancy | 0 minute to day 99 after administration | |
| The incidence of positive ADA | 0 minute to day 99 after administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Beijing | Beijing Municipality | 100191 | China |
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SHR-3032 for dose escalation
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| SHR-3032 Placebo |
| Drug |
Single dose at varying dosage levels depending on treatment assignment |
|