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The study is being conducted to Evaluate the Safety, Tolerability and Pharmacokinetics pharmacodynamics of SHR-2010 by intravenously/subcutaneously in Healthy Subject.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment for intravenously/subcutaneously | Experimental | Treatment for intravenously: 6 dose groups; Treatment for subcutaneously: 3 dose groups. |
|
| Placebo for intravenously/subcutaneously | Placebo Comparator | Treatment for intravenously: 6 dose groups; Treatment for subcutaneously: 3 dose groups. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-2010 injection | Drug | Treatment for intravenously: 6 subjects for SR-2010 injection. Treatment for subcutaneously: 8 subjects for SR-2010 injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability: Incidence of subjects with adverse events (AEs) | Incidence of AEs, including any abnormal findings in vital signs, and/or physical examination and/or clinical laboratory assessments and/or 12-lead ECG evaluation and/or IGRA. | Baseline up to Day 85 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) parameter: AUC0-t for SHR-2010 | AUC0-t: Area under the plasma concentration-time curve from time zero to the time of last quantifiable analyte concentration | Baseline up to Day 85 |
| Pharmacokinetics (PK) parameter: AUC0-∞ for SHR-2010 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Hospital of Qingdao University | Qingdao | Shandong | 266555 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40297949 | Derived | Lin P, Wang C, Hu X, Fang L, Lin H, Sun F, Huang R, Ban R, Feng S, Gao Z, Shen K, Cao Y. Safety, tolerability, pharmacokinetics, and pharmacodynamics of SHR-2010, a novel anti-MASP-2 antibody, in healthy volunteers: a randomized, double-blind, placebo-controlled phase 1 study. Expert Opin Investig Drugs. 2025 Apr;34(4):339-348. doi: 10.1080/13543784.2025.2500291. Epub 2025 May 1. | |
| 38299639 |
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SHR-2010 injection compared with placebo
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| SHR-2010 injection placebo | Drug | Treatment for intravenously: 2 subjects for placebo. Treatment for subcutaneously: 2 subjects for placebo. |
|
AUC0-∞: Area under the plasma concentration-time curve from time zero extrapolated to infinity |
| Baseline up to Day 85 |
| Pharmacokinetics (PK) parameter: Cmax for SHR-2010 | Cmax: Maximum plasma concentration | Baseline up to Day 85 |
| Pharmacokinetics (PK) parameter: Tmax for SHR-2010 | Tmax: Time to reach maximum plasma concentration | Baseline up to Day 85 |
| Pharmacokinetics (PK) parameter: t1/2 for SHR-2010 | t1/2: Terminal half-life | Baseline up to Day 85 |
| Pharmacokinetics (PK) parameter: CL of SHR-2010 for administration intravenously | CL: Clearance | Baseline up to Day 85 |
| Pharmacokinetics (PK) parameter: CL/F of SHR-2010 for administration subcutaneously | CL/F: Apparent clearance | Baseline up to Day 85 |
| Pharmacokinetics (PK) parameter: V of SHR-2010 for administration intravenously | V: Volume of distribution | Baseline up to Day 85 |
| Pharmacokinetics (PK) parameter: V/F of SHR-2010 for administration subcutaneously | V/F: Apparent volume of distribution | Baseline up to Day 85 |
| Pharmacokinetics (PK) parameter: Bioavailability (F) of SHR-2010 | Bioavailability of SHR-2010 for administration subcutaneously. | Baseline up to Day 85 |
| Pharmacodynamics (PD): C4b level in the serum | C4b level in the serum. | Baseline up to Day 85 |
| Immunogenicity: Proportion of anti-drug antibodies (ADA) positive subjects | Proportion of anti-drug antibodies (ADA) positive subjects. | Baseline up to Day 85 |
| Derived |
| Tunnicliffe DJ, Reid S, Craig JC, Samuels JA, Molony DA, Strippoli GF. Non-immunosuppressive treatment for IgA nephropathy. Cochrane Database Syst Rev. 2024 Feb 1;2(2):CD003962. doi: 10.1002/14651858.CD003962.pub3. |
| ID | Term |
|---|---|
| D005922 | Glomerulonephritis, IGA |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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