Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XJ103 Injection | Experimental | Participants will receive a single dose of XJ103 intravenously. |
|
| Placebo | Placebo Comparator | Participants will receive a single dose of placebo intravenously. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XJ103 Injection | Drug | XJ103 is a humanized monoclonal antibody. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of any adverse events that occurred among all subjects during the clinical trial | From the time of informed consent through 358 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 358 days post dose. | |
| Area Under the Serum Concentration Time Curve from Time Zero to Last Measurable Concentration (AUC [0-Last]) | From Day 1 through 358 days post dose. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
Not provided
| ID | Term |
|---|---|
| D011008 | Pneumococcal Infections |
| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Drug |
Placebo contains only excipients. |
|
| Maximum Observed Serum Concentration (Cmax) | From Day 1 through 358 days post dose. |
| Terminal Phase Elimination Half-life (t1/2) | From Day 1 through 358 days post dose. |
| Elimination Rate Constant (Kel) | From Day 1 through 358 days post dose. |
| Mean Residence Time (MRT) | From Day 1 through 358 days post dose. |
| Apparent Serum Clearance (CL) | From Day 1 through 358 days post dose. |
| Apparent Volume of Distribution (Vd) | From Day 1 through 358 days post dose. |
| Percentage of Area Under the Serum Concentration Time Curve That Has Been Derived After Extrapolation (AUC_% Extrap) | From Day 1 through 358 days post dose. |
| Proportion of Participants Positive for Anti-drug Antibodies (ADA) | From Day 1 through 358 days post dose. |
| Titer Range of Anti-drug Antibodies (ADA) | From Day 1 through 358 days post dose. |
| D007239 | Infections |