MedTrace Logo

A Clinical Study in Health Subjects to Evaluate 9MW1411 Injection

NCT04784312 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2022-06-15

No results posted yet for this study

Summary

This is a Phase 1, first time in human study enrolling approximately 42 healthy adult subjects (18-45 yrs) from one study site. The purpose of this study is to evaluate the safety, tolerability and PK of MW14 in healthy adult volunteers administered as a single IV dose compared with placebo, across 5 cohorts. The 5 dose cohorts will enroll sequentially. Subjects will be followed for safety from the time of Informed Consent through 85 days post dose.

Conditions

  • Staphylococcus Aureus Infection

Interventions

COMBINATION_PRODUCT

9MW1411 injection

9MW1411 injection

COMBINATION_PRODUCT

9MW1411 injection placebo

9MW1411 injection placebo

Sponsors & Collaborators

  • Huashan Hospital

    collaborator OTHER

  • Mabwell (Shanghai) Bioscience Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-16
Primary Completion
2021-08-17
Completion
2021-08-17

Countries

  • China

Study Locations

More Related Trials

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 NCT04784312 on ClinicalTrials.gov