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This trail will investigate the pharmacokinetics and safety of IBI310 and establish pharmacokinetics biosimilarity of IBI310 to ipilimumab ļ¼YERVOYļ¼
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group B: ipilimumab | Active Comparator | Ipilimumab, 0.1 and 0.3mg/kg, will be administrated intravenously in 30-60 minutes. |
|
| Group A: IBI310 | Experimental | IBI 310, 0.1 and 0.3mg/kg, will be administrated intravenously in 30-60 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ipilimumab | Drug | Drug: Ipilimumab 0.1 mg/kg and 0.3 mg/kg in preparatory experiments and 0.3 mg/kg in formal experiment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve (AUC0-inf) | From pre-dose to 1848hrs (78day) | |
| Maximum Plasma Concentration (Cmax) | From pre-dose to 1848hrs (78day) |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve | From pre-dose to 1848hrs (78day) | |
| Clearance | From pre-dose to 1848hrs (78day) | |
| Volume of distribution |
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Inclusion Criteria:
To be eligible for the study, patients should fulfill all the following criteria:
Exclusion Criteria:
Patients should not enter the study if any of the following exclusion criteria are fulfilled:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital Affiliated to Fudan University | Shanghai | China |
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| ID | Term |
|---|---|
| D000074324 | Ipilimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| IBI310 | Drug | Drug: IBI310 0.1 mg/kg and 0.3 mg/kg in preparatory experiments and 0.3 mg/kg in formal experiment. |
|
| From pre-dose to 1848hrs (78day) |
| Positive rate of ADA and Nab | From pre-dose to 1848hrs (78day) |
| incidence and severity of adverse events | Number of subjects with AEļ¼treatment-related AE (TRAE), immune-related AEs (irAE), serious adverse SAE assessed by CTCAE V5.0 | from dosing to completion of study (183days posy-dosing) or to the patient withdrawl |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |