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This is a randomized, double-blind, placebo-parallel intervention clinical study that will include approximately 38 healthy subjects based on inclusion and exclusion criteria. Subjects will be assigned to one of four different dosage cohorts. Subjects in each cohort will randomly be given experimental drug or a placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XJ101 for Injection | Experimental | XJ101 via intravenous(IV). |
|
| Placebo | Placebo Comparator | Placebo via intravenous(IV). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XJ101 for Injection | Drug | XJ101 is a recombinant humanized single domain antibody-Fc (human immunoglobulin G1 type) fusion protein. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Any adverse events that occurred among all subjects during the clinical trial, including clinical symptoms, vital signs or physical examination abnormalities, laboratory tests or 12-lead electrocardiogram abnormalities. | From the time of informed consent through 92 days post dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Serum Concentration Time Curve from Time Zero to Infinity (AUC [0-Infinity]) | From Day 1 through 92 days post dose. | |
| Area Under the Serum Concentration Time Curve from Time Zero to Last Measurable Concentration (AUC [0-Last]) | From Day 1 through 92 days post dose. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ding xueying | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai General Hospita | Shanghai | Shanghai Municipality | 200080 | China |
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| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| Placebo | Drug | Placebo contains only excipients. |
|
| Maximum Observed Serum Concentration (Cmax) | From Day 1 through 92 days post dose. |
| Terminal Phase Elimination Half-life (t1/2) | From Day 1 through 92 days post dose. |
| Elimination Rate Constant (Kel) | From Day 1 through 92 days post dose. |
| Mean Residence Time (MRT) | From Day 1 through 92 days post dose. |
| Apparent Serum Clearance (CL) | From Day 1 through 92 days post dose. |
| Apparent Volume of Distribution (Vd) | From Day 1 through 92 days post dose. |
| Percentage of Area Under the Serum Concentration Time Curve That Has Been Derived After Extrapolation (AUC_% Extrap) | From Day 1 through 92 days post dose. |
| Anti Drug Antibody (ADA) Assessments - Serum | ADA responses to XJ101 | From Day 1 through 92 days post dose. |