A Phase I Study of XJ103 in Chinese Healthy Subjects

Study Overview
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Brief Summary
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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.

Official Title
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A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of XJ103 in Chinese Healthy Subjects

Conditions
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Pneumococcal Disease

Intervention / Treatment
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* Drug: XJ103 Injection
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 through 45 years at screening. Male weight ≥ 50.0 kg, female weight ≥ 45.0 kg, and body mass index (BMI) within the range of 19.0 to 26.0 kg/m2 (including critical values). The subjects have no pregnancy plan and voluntarily avoid pregnancy from signing the informed consent form until the end of the trail. Healthy on the basis of physical examination and medical and surgical history and twelve-lead electrocardiogram (ECG) without clinically relevant abnormalities. Written informed consent and any locally required authorization (eg, HIPAA) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations. Exclusion Criteria: Subjects with any abnormalities of respiratory system, circulatory system, digestive system, nervous system, skeletal muscle system, blood and lymphatic system, immune system and endocrine system. History of allergy to drugs or biological products or individuals with allergic constitution. Acute infection within 4 weeks prior to study entry. Suffer from diseases caused by streptococcus pneumoniae within 1 year prior to study entry, such as pneumococcal pneumonia, pneumococcal meningitis, etc. Receipt of any standard vaccine against streptococcus pneumoniae before the study period. Receipt of any standard vaccine within 4 weeks prior to investigational product dosing or plan to vaccinate during the study period. Receipt of any major surgery within 3 months prior to the start of the trial, or have not recovered from surgery, or plan to have a surgical during the trial. Those who cannot tolerate venipuncture, or have a history of injector and blood sickness, or are not suitable for venous blood collection. Subjects with a history of drug abuse or drug use, or those with positive urine drug screening. Blood donation or massive blood loss (> 200 mL) within three months prior to screening or plan to donate blood, receive blood transfusions, or use blood products during the trial period or within 1 month after the end of the trial. Pregnant or lactating women. Use of any prescription drugs, over-the-counter drugs, vitamin products or herbal medicines within 14 days prior to screening. Smoke more than 5 cigarettes per day within three months prior to screening. Frequent drinkers in the three months before screening, i.e. those who drink more than or equal to 14 units of alcohol per week on average (1 unit=17.7 ml ethanol, 1 unit=354 ml beer with 5% alcohol, 44.25 ml spirits with 40% alcohol, or 147.5 ml wine with 12% alcohol), or those who do not agree to ban alcohol during the study period. Evidence of infection with HBV, hepatitis C, HIV, or syphilis. Positive alcohol breath test. Subjects with special dietary requirements or cannot accept a unified diet. Participation in other clinical trials within three months prior to enrollment or plan to participate in other clinical trials during this period. Any other factors evaluated by investigators that patients cannot be enrolled.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: XJ103 Injection<br>Participants will receive a single dose of XJ103 intravenously. | Drug: XJ103 Injection<br>* XJ103 is a humanized monoclonal antibody.<br>|
| Placebo Comparator: Placebo<br>Participants will receive a single dose of placebo intravenously. | Drug: Placebo<br>* Placebo contains only excipients.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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. | 
| 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. |