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Skin InfectionPhase 2NCT05339802

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

A Phase 2 study testing 9MW1411 injection 1 combined with Linezolid and 9MW1411 injection 2 combined with Linezolid in people with Skin Infection, run by Mabwell (Shanghai) Bioscience Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

In this study, a multicenter, randomized, double-blind, placebo-controlled trial design is used to evaluate the efficacy and safety of two doses of 9MW1411 injection in patients with ABSSSI caused by S. aureus. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Skin Infection
What is being tested?
9MW1411 injection 1 combined with Linezolid and 9MW1411 injection 2 combined with Linezolid
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
90 participants
Where
1 siteChina
Study dates
16 Feb 2022to Dec 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female subjects aged 18 to 75 years (including 18 and 75 years);
  • One of the following types of skin and skin structure infection is met:
  • 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.
  • 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.
  • 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.
  • 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.
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  • 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.
  • Subjects must have at least two of the following signs/symptoms:
  • Drainage or discharge of pus;
  • Erythema;
  • Fluctuation sensation;
  • Increased skin temperature;
  • Edema or induration;
  • Tenderness;
  • Patients with systemic reactions that meet any of the following:
  • 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;
  • 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%;
  • Involvement of lymphatic system: lymphangitis or lymphadenopathy in or adjacent areas of lymphatic drainage at the site of infection;
  • S. aureus infection is judged by any of the following methods prior to randomization:
  • 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;
  • 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.
  • 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:
  • 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;
  • 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;
  • Willingness to sign informed consent forms (ICFs);
  • Subjects who can communicate effectively with the investigator, understand and agree to comply with the requirements of this study.

Who cannot join

  • Patients with uncomplicated skin and skin structure infections, such as furuncles, minor abscesses (no cellulitis/erysipelas around the suppurative area), pustular lesions, superficial or localized cellulitis/erysipelas, and small wound infections (eg, suture abscesses).
  • Patients with confirmed or suspected acute infection of skin and skin structures caused solely by gram-negative bacteria or anaerobes, fungi, and parasites.
  • Presence of any of the following infections:
  • Patients with confirmed or suspected osteomyelitis; Patients with confirmed or suspected suppurative arthritis; Patients with implant devices that cannot be removed at the site of infection, such as artificial joints, intravascular catheters, and batteries of permanent pacemakers, etc.; Patients with previous chronic dermatitis or other chronic inflammatory skin lesions, such as eczema and psoriasis, which may affect the judgement of their treatment response; Patients with pressure ulcer infection; Patients with life-threatening infections or infections requiring emergency surgery, such as necrotizing fasciitis, progressive gangrene, and endocarditis, etc.; Patients with infection after human or animal bites (except arthropods).
  • Evidence of any of the following serious immune system disorders:
  • Patients with current or expected neutropenia reducing, defined as neutrophil count < 1.5 x 109/L; Patients received cancer chemotherapy, radiotherapy, or strong non-corticosteroid immunosuppressive drugs (e.g., cyclosporine, azathioprine, tacrolimus, immunomodulatory monoclonal antibody therapy, etc.) within the past 3 months; Patients received prednisone at a dose of ≥ 20 mg/day for more than 14 days or an estimated course of treatment more than 14 days prior to enrollment.
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  • Patients with known or clinically suspected one or more of the following: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) is 3 times higher than the upper limit of normal (ULN); total bilirubin is 2 times higher than the ULN, or evidence of end-stage liver disease (eg, ascites, hepatic encephalopathy).
  • Patients with history or evidence of severe renal disease, or known creatinine clearance (CrCl) < 50 mL/min (estimated using the Cockcroft-Gault formula), or requiring peritoneal dialysis, plasma exchange, hemodialysis, veno-venous dialysis, or other forms of renal filtration.
  • Patients with active or history of autoimmune diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, multiple sclerosis, vasculitis, etc.) that may relapse, or patients who are at high risks (e.g., organ transplant requiring immunosuppressive therapy).
  • Patients with uncontrolled or uncontrollable hypertension (systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg), pheochromocytoma, carcinoid syndrome, or hyperthyroidism.
  • Patients with serious or life-threatening condition or organ/system disorders (eg, endocarditis, meningitis, unstable central nervous system disorder, acidosis, or history of lactic acidosis).
  • Patients with burn infection have any of the following: ①Patients with burns of special causes, such as electrical injury, chemical burns, or burns combined with compound injuries (except for arc burns); ②Patients with moderate to severe inhalation injury, severe combined injures, acute respiratory distress syndrome, multiple organ failure, disseminated intravascular coagulation, or acute cardiac insufficiency.
  • Patients with diabetic foot have any of the following: ①Patients with uncontrolled blood glucose (fasting blood glucose > 10 mmol/L) and all types of diabetic coma; ②Patients with canceration at the ulcer site; ③Patients with vascular hypoperfusion of the affected limb, ankle-brachial index (ABI) < 0.6, requiring angioplasty; ④Patients with wound infection with gangrene, which cannot be appropriately cleared by debridement; ⑤The investigator believes that it is likely that a lower knee amputation is necessary.
  • The investigator believes that the subject had any underlying medical conditions affecting participation in the study, including serious heart disease, malignancy, psychosis, ongoing treatment for epilepsy, or a history of untreated epilepsy.

Trial locations and contacts

1 site in 1 country.

Shaoqing ZENG, Bachelor contact

021-58585793

shaoqing.zeng@mabwell.com

China1 site, 1 recruiting

  • Huashan Hospital affiliated to Fudan University

    Shanghai, Shanghai Municipality, 20040

    Wang N minggui, MD, 02152887926, mgwang@fudan.edu.cn

    Recruiting

Other trials in China

About this study

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Study of the Efficacy and Safety of 9MW1411 Injection Combined With Antibiotics in Patients With Acute Staphylococcus Aureus Skin and Skin Structure Infection

In this study, a multicenter, randomized, double-blind, placebo-controlled trial design is used to evaluate the efficacy and safety of two doses of 9MW1411 injection in patients with ABSSSI caused by S. aureus.

The Recommended Phase 2 Dose (RP2D) of 9MW1411 injection for this placebo-controlled study is comprehensively selected based on the results of Phase I clinical trials and preclinical PK/PD analysis. Approximately 90 subjects with ABSSSI caused by S. aureus are planned to be enrolled, and the infection type and presence or absence of single S. aureus infection will be used as randomization stratification factors for all randomized subjects. They are randomized in a 1: 1: 1 ratio.

Read the detailed description

This study used a multicenter, randomized, double-blind, placebo-controlled trial design to evaluate the efficacy and safety of two doses of 9MW1411 injection in patients with acute staphylococcus aureus skin and skin structure infection.

Conditions
Skin Infection
Being tested
9MW1411 injection 1 combined with Linezolid, 9MW1411 injection 2 combined with Linezolid, 9MW1411 injection placebo combined with Linezolid
Medical subject headings
Cellulitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 9MW1411 injection 1 combined with LinezolidCombination product

    After randomization, 9MW1411 injection, single dose, intravenous infusion, linezolid: 600mg, given intravenously or orally every 12 hours, for a total course of treatment not exceeding 14 days.

  • 9MW1411 injection 2 combined with LinezolidCombination product

    After randomization, 9MW1411 injection, single dose, intravenous infusion, linezolid: 600mg, given intravenously or orally every 12 hours, for a total course of treatment not exceeding 14 days.

  • 9MW1411 injection placebo combined with LinezolidCombination product

    After randomization, 9MW1411 injection placebo, single dose, intravenous infusion, linezolid: 600mg, given intravenously or orally every 12 hours, for a total course of treatment not exceeding 14 days.

Study groups in NCT05339802
Study groupRoleWhat they receive
Cohort 1Experimental9MW1411 injection , single administration, intravenous infusion, infusion time 2H (120 ± 15min);
Receives: Combination Product: 9MW1411 injection 1 combined with Linezolid
Cohort 2Experimental9MW1411 injection , single administration, intravenous infusion, infusion time 2H (120 ± 15min);
Receives: Combination Product: 9MW1411 injection 2 combined with Linezolid
PlaceboPlacebo comparator9MW1411 injection placebo, single administration, intravenous infusion, infusion time: 2h (120 ± 15min)
Receives: Combination Product: 9MW1411 injection placebo combined with Linezolid

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical cure in the mITT Population at the Test of cure (TOC) Visit

    Evaluate the Efficacy of 9MW1411

    Measured: TOC:Test of cure; 14 days after the last day of linezolid therapy.

  2. Incidence and severity of adverse events (AEs)，serious adverse event (SAEs)

    Evaluate the Safety of 9MW1411

    Measured: From day 1 to day 57（±7） after administration

  3. Incidence of abnormal clinical laboratory findings in 12-lead ECG parameters, vital signs, physical examination

    Evaluate the Safety of 9MW1411

    Measured: Screening (within 48 hours prior to the first dose of test article) to Follow-up (Day 57±7)

  4. Maximum Observed Concentration (Cmax)

    Evaluate the pharmacokinetics profile of 9MW1411

    Measured: From day 1 to day 57（±7） after administration

  5. Incidence of anti-drug antibodies

    Evaluate the immunogenicity of 9MW1411

    Measured: From day 1 to day 57（±7） after administration

Secondary outcomes (1)

  1. Eearly clinical response at 48h~72h after first dose of 9MW1411

    Evaluate the Efficacy of 9MW1411

    Measured: 48h~72h after first dose of 9MW1411

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2022
  2. Study start16 Feb 2022
  3. Primary completionOct 2023 (estimated)
  4. Study completionDec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05339802
Sponsor's protocol ID
9MW1411-2021-CP201
Status last verified
Apr 2022
First submitted
16 Nov 2021
Last updated
21 Apr 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 9MW1411 injection 1 combined with Linezolid and 9MW1411 injection 2 combined with Linezolid in people with Skin Infection, run by Mabwell (Shanghai) Bioscience Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 26 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Shaoqing ZENG, Bachelor (021-58585793, shaoqing.zeng@mabwell.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical cure in the mITT Population at the Test of cure (TOC) Visit (time frame: TOC:Test of cure; 14 days after the last day of linezolid therapy.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05339802.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2022.

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