Status:
ACTIVE_NOT_RECRUITING
A Phase I Study of XJ101 in Chinese Healthy Subjects
Lead Sponsor:
Starmab biologics（Shanghai）Co,.ltd
Conditions:
Staphylococcus Aureus Bloodstream Infection
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
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 assigne...
Eligibility Criteria
Inclusion
- 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
- 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.
- Acute infection within 4 weeks prior to study entry.
- Suffer from diseases caused by Staphylococcus aureus within one year, such as bacteremia, sepsis and pyemia.
- 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 and 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.
Key Trial Info
Start Date :
August 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2024
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT06014736
Start Date
August 15 2023
End Date
September 1 2024
Last Update
June 14 2024
Active Locations (1)
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1
Shanghai General Hospita
Shanghai, Shanghai Municipality, China, 200080