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The primary objective of this phase Ib study is to evaluate the safety and tolerability of multiple-ascending, subcutaneous (SC) doses of HC022 in SLE/CLE subjects. Secondary objectives of study are as follows: To estimate the PK parameters of multiple-ascending SC doses of HC022 in SLE/CLE subjectsï¼›To evaluate the immunogenicity of HC022 administered to SLE/CLE subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HC022 100mg | Experimental | Participants will receive subcutaneous (SC) dose of 100 mg HC022 or matching placebo with a dosing frequency of Q4W (once every 4 weeks), administered subcutaneously twice. |
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| HC022 225mg | Experimental | Participants will receive subcutaneous (SC) dose of 225mg HC022 or matching placebo with a dosing frequency of Q4W (once every 4 weeks), administered subcutaneously twice. |
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| HC022 450mg | Experimental | Participants will receive subcutaneous (SC) dose of 450mg HC022 or matching placebo with a dosing frequency of Q4W (once every 4 weeks), administered subcutaneously twice. |
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| HC022 450mg-2 | Experimental | Participants will receive subcutaneous (SC) dose of 450mg HC022 or matching placebo with a dosing frequency of Q4W (once every 4 weeks),1 additional dose at the end of Week 2 (D15) for a total of 3 doses |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HC022 | Drug | Administered as specified in the treatment arm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose: Results in death; in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event); however, this does not include an event that, had it occurred in a more severe form, might have caused death; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect. | Up to day 141 |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-Time Curve From Time 0 to 28 Days Post-dose (AUC0-28d) | UP to day 28 | |
| Area Under the Concentration-Time Curve From Time 0 to the Time of the Last Measurable Concentration (AUClast) | Up to day 141 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| QiQi huang Huang, master | Contact | 18221247718 | qiqi.huang@btyy.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | 100730 | China |
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| Placebo | Drug | Administered as specified in the treatment arm |
|
| Cmax of HC022 | Up to day 141 |
| Terminal Elimination Half-Life (t1/2) of HC022 | Up to day 141 |
| Apparent Clearance (CL/F) of HC022 | Up to day 141 |
| Number of Participants Who Develop Serum Anti-HC022 Antibodies | Up to day 141 |
| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| D008178 | Lupus Erythematosus, Cutaneous |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D012871 | Skin Diseases |
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