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The primary objective of this phase Ia study is to evaluate the safety and tolerability of single-ascending, subcutaneous (SC) doses of HC022 in healthy subjects. Secondary objectives of study are as follows: To estimate the PK parameters of single-ascending SC doses of HC022 in healthy subjectsï¼›To evaluate the immunogenicity of HC022 administered to healthy subjects.
This is a first-in-human study of HC022 to assess safety, tolerability, and pharmacokinetic (PK) and pharmacodynamic (PD) effects of single HC022 doses in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HC022 5mg SC | Experimental | Participants will receive single subcutaneous (SC) dose of 5 mg HC022 or matching placebo on Day 1. |
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| HC022 50mg SC | Experimental | Participants will receive single subcutaneous (SC) dose of 50 mg HC022 or matching placebo on Day 1. |
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| HC022 150mg SC | Experimental | Participants will receive single subcutaneous (SC) dose of 150 mg HC022 or matching placebo on Day 1. |
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| HC022 450mg SC | Experimental | Participants will receive single subcutaneous (SC) dose of 450 mg HC022 or matching placebo on Day 1. |
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| HC022 900mg SC | Experimental | Participants will receive single subcutaneous (SC) dose of 900 mg HC022 or matching placebo on Day 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HC022 | Drug | Administered as specified in the treatment arm |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to 20 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-Time Curve from Time 0 Extrapolated to Infinity (AUCinf) of HC022 | Up to 20 weeks | |
| Maximum Observed Concentration (Cmax) of HC022 | Up to 20 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Langxi Zhang, PhD | Contact | 8602150433368 | langxi.zhang@btyy.com | |
| The Clinical Pharmacology Research Center of PUMCH | Contact |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Not yet recruiting | Beijing | 100730 | China |
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| Placebo | Drug | Administered as specified in the treatment arm |
|
| Time to Reach Maximum Observed Concentration (Tmax) of HC022 |
| Up to 20 weeks |
| Terminal Elimination Half-Life (t1/2) of HC022 | Up to 20 weeks |
| Apparent Clearance (CL/F) of HC022 | Up to 20 weeks |
| Apparent Volume of Distribution (Vz/F) of HC022 | Up to 20 weeks |
| Number of Participants Who Develop Serum Anti-HC022 Antibodies | Up to 20 weeks |
| Peking Union Medical College Hospital | Recruiting | Beijing | China |
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| The Clinical Pharmacology Research Center of PUMCH | Recruiting | Beijing | China |
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