A Phase I Study of XJ101 in Chinese Healthy Subjects (NCT06014736) | Clinical Trial Compass
UnknownPhase 1
A Phase I Study of XJ101 in Chinese Healthy Subjects
China38 participantsStarted 2023-08-15
Plain-language 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 assigned to one of four different dosage cohorts. Subjects in each cohort will randomly be given experimental drug or a placebo.
Who can participate
Age range18 Years – 45 Years
SexALL
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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.
✕. 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.
What they're measuring
1
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.
Timeframe: From the time of informed consent through 92 days post dose.