A Phase Ⅱ Clinical Study of 9MW1411 Injection in Acute Bacterial Skin and Skin Structure Infections

Inclusion Criteria

• •1. Male or female subjects aged 18 to 75 years (including 18 and 75 years);
• •2. One of the following types of skin and skin structure infection is met:
• •1. Cellulitis: A diffuse skin infectious disease characterized by diffuse congestion (erythema), edema and/or induration within 7 days of the Screening Visit. The lesion area is at least 75 cm2, calculated as the longest diameter (along the head-to-foot of the human body) multiplied by the widest diameter (perpendicular to the longest diameter), which are measured by the investigator with a ruler.
• •2. Wound infection: An infectious disease characterized by purulent drainage from a wound or surgical wound, periwound congestion (erythema), edema and/or induration within 7 days of the Screening Visit. The shortest diameter measured from the perimeter of the wound is at least 5 cm and the lesion area is at least 75 cm2, calculated as the longest diameter (along the head-to-foot of the human body) multiplied by the widest diameter (perpendicular to the longest diameter), which are measured by the investigator with a ruler.
• •3. Large cutaneous abscess: An infectious disease characterized by congestion (erythema), edema, and/or induration with collection of pus in the dermis or deeper for the first time within 7 days of the Screening Visit. The shortest diameter measured from the periphery of the abscess is at least 5 cm and the lesion area is at least 75 cm2, calculated as the longest diameter (along the head-to-foot of the human body) multiplied by the widest diameter (perpendicular to the longest diameter), which are measured by the investigator with a ruler.
• •4. Burn infection: An infectious disease characterized by purulent drainage with congestion (erythema), edema and/or induration. The shortest diameter measured from the periphery of the burn infection is at least 5 cm and the lesion area is at least 75 cm2 (burn depth is Grade II or higher), calculated as the longest diameter (along the head-to-foot) multiplied by the widest diameter (perpendicular to the longest diameter), which are measured by the investigator with a ruler. Burns occur within 7 days prior to the Screening Visit and cover 10% to 50% of their total body surface area. Patients with burn infections do not exceed 20% of all subjects.
• •5. Diabetic foot infection: The subject meets diagnostic criteria for type 1 or 2 diabetes and meets the Infectious Diseases Society of America/International Working Group on Diabetic Foot (IDSA/IWGDF) criteria for moderate infection of diabetic foot (Appendix 1): patients with infection have good systemic function and stable metabolism. However, the patient has ≥ 1 of the following characteristics: ①cellulitis extending \> 2 cm around the ulcer, ② lymphatic stripes, ③spreading beneath the superficial fascia, ④deep tissue abscesses; The subject meets the diagnostic criteria for diabetic foot and Wagner grade 2 (Appendix 2) that the ulcer lesion time \< 4 weeks: ①If multiple ulcer lesions are present at the same time, the largest lesion is selected as the observed lesion; ②The ulcer lesion is measurable and the lesion area is ≥ 5 cm2, which is calculated as the longest diameter (along the head-foot of the human body) multiplied by the widest diameter (perpendicular to the longest diameter), which are measured by the investigator with a ruler. Patients with diabetic foot infection do not exceed 10% of all subjects.
• •3. Subjects must have at least two of the following signs/symptoms:
• •1. Drainage or discharge of pus;
• •2. Erythema;
• •3. Fluctuation sensation;
• •4. Increased skin temperature;
• •5. Edema or induration;
• •6. Tenderness;
• •4. Patients with systemic reactions that meet any of the following:
• •1. Fever, defined as oral temperature ≥ 38 °C or axillary temperature ≥ 37.5 °C, or decreased body temperature, i.e., oral temperature \< 35 °C or axillary temperature \< 34.5 °C;
• •2. Peripheral blood white blood cell count ≥ 10 × 109/L or \< 4 × 109/L, or neutrophil percentage increased (exceeds the upper limit of the reference value) or banded granulocytes ≥ 15%;
• •3. Involvement of lymphatic system: lymphangitis or lymphadenopathy in or adjacent areas of lymphatic drainage at the site of infection;
• •5. S. aureus infection is judged by any of the following methods prior to randomization:
• •1. Rapid diagnostic tests, e.g. FA from BioFire, GX from Cepheid, mass spectrometry, PCR, microarray, second-generation sequencing, etc., are used for preliminary judgement of S. aureus infection. At the same time, the same samples are also used for standard microbial culture without the need to obtain microbial culture results prior to randomization;
• •2. Standard microbial culture tests for S. aureus obtained within 72 hours prior to randomization. This sample may be used as a baseline standard microbial culture (including microbial identification, quantitative or semi-quantitative cultures, and susceptibility testing) by each site laboratory.
• •6. Subjects do not have a fertility plan or sperm donation plan during the study and for 6 months after the end of the study, and voluntarily take effective contraceptive measures:
• •1. Female subjects must meet the following conditions: ①non-pregnant or lactating; ②have undergone surgical sterilization or amenorrhea for at least 1 year; ③female subjects of childbearing potential have a negative blood pregnancy test before randomization, and agree to use an effective contraceptive method (e.g., oral contraceptives, condoms, or intrauterine devices) throughout the study or consent to abstinence throughout the study;
• •2. Male subjects of childbearing potential agree to use effective barrier contraceptive measures (e.g., condoms) during the study, or their partners agree to use effective contraceptive methods for female subjects as described above, or consent to abstinence throughout the study;
• •7. Willingness to sign informed consent forms (ICFs);
• •8. Subjects who can communicate effectively with the investigator, understand and agree to comply with the requirements of this study.