NCT05339802

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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. 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.

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

Interventions

Type	Name	Description
COMBINATION_PRODUCT	9MW1411 injection 1 combined with Linezolid	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.
COMBINATION_PRODUCT	9MW1411 injection 2 combined with Linezolid	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.
COMBINATION_PRODUCT	9MW1411 injection placebo combined with Linezolid	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.

Timeline

• Start date: 2022-02-16
• Primary completion: 2023-10-01
• Completion: 2023-12-01
• First posted: 2022-04-21
• Last updated: 2022-04-21

Locations

1 site across 1 country: China