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It is designed for Multi-center, double-masked, randomized, placebo- control study with dose escalation phase I trial to evaluate the safety, tolerability, PK and immunogenicity profiles of a single intravenous injection of IBI311 in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: treated with different doses of single intravenous injection of IBI311 | Experimental |
| |
| Cohort 1: placebo group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo | Biological | Dose4 placebo of single IV injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence, relatedness and severity of all adverse events, treatment emergent adverse events and serious adverse events | Up to 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| maximum concentration (Cmax) | PK parameters maximum concentration (Cmax) of IBI311 | Up to 16 weeks. |
| area under the curve (AUC) | PK parameters area under the curve (AUC) of IBI311 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yongfang Yuan, Ph D. | Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine | Shanghai | Shanghai Municipality | 200041 | China |
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| IBI311 |
| Biological |
Dose2 IBI311 of single IV injection |
|
| IBI311 | Biological | Dose4 IBI311 of single IV injection |
|
| placebo | Biological | Dose3 placebo of single IV injection |
|
| placebo | Biological | Dose1 placebo of single IV injection |
|
| IBI311 | Biological | Dose1 IBI311 of single IV injection |
|
| IBI311 | Biological | Dose 3 IBI311 of single IV injection |
|
| placebo | Biological | Dose2 placebo of single IV injection |
|
| Up to 16 weeks. |
| half-life (t1/2) | PK parameters half-life (t1/2) of IBI311 | Up to 16 weeks. |
| the incidence of ADA | Positive rate of anti-drug antibody | Up to 16 weeks |