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

NCT05339802 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2022-04-21

No results posted yet for this study

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.

Conditions

  • Skin Infection

Interventions

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.

Sponsors & Collaborators

  • Mabwell (Shanghai) Bioscience Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yang NA liecheng, master · Mabwell (Shanghai) Bioscience Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-16
Primary Completion
2023-10-31
Completion
2023-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05339802 on ClinicalTrials.gov