A Clinical Study in Health Subjects to Evaluate 9MW1411 Injection

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04784312
Study type	Interventional
Source	Mabwell (Shanghai) Bioscience Co., Ltd.
Contact
Status	Completed
Phase	Phase 1
Start date	April 16, 2021
Completion date	August 17, 2021

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT04210505` - Nasal Decolonization of Dialysis Patients Noses	Phase 4
Not yet recruiting	`NCT05361135` - 18-fluorodeoxyglucose Positron Emission Tomography/Computed Tomography in S. Aureus Bacteraemia	N/A
Completed	`NCT02804711` - A Clinical Trial to Evaluate a Recombinant Staphylococcus Aureus Vaccine (Escherichia Coli) in Healthy Adults	Phase 1
Completed	`NCT02282605` - Study of the Nasal Decolonisation of Staphylococcus Aureus (SA) and the Safety and Tolerability of XF-73 Nasal Gel in Healthy Subjects	Phase 1/Phase 2
Recruiting	`NCT06319235` - Clinical Trial to Demonstrate the Safety and Efficacy of DUOFAG®	Phase 1/Phase 2
Enrolling by invitation	`NCT06317688` - Effectiveness of Highly Purified Anhydrous (HPA) Lanolin Versus Extra-Virgin Coconut Oil in Preventing Subacute Lactation Mastitis	Phase 1
Withdrawn	`NCT02741869` - Photodisinfection for the Decolonization of Staphylococcus Aureus in Hemodialysis Patients	N/A
Completed	`NCT03966040` - A Clinical Trial to Evaluate a Recombinant Staphylococcus Aureus Vaccine (Escherichia Coli) in Healthy Adults	Phase 1
Completed	`NCT04803708` - Bacteriophage Therapy TP-102 in Diabetic Foot Ulcers	Phase 1/Phase 2
Recruiting	`NCT05117398` - Dalbavancin Versus Standard Antibiotic Therapy for Catheter-related Bloodstream Infections Due to Staphylococcus Aureus	Phase 3
Not yet recruiting	`NCT06456424` - Bacteriophage Therapy for Methicillin-Sensitive Staphylococcus Aureus Prosthetic Joint Infection	Phase 1/Phase 2
Completed	`NCT02820883` - A Study of a Recombinant Staphylococcus Aureus Vaccine (Escherichia Coli) in Healthy Adults	Phase 0
Active, not recruiting	`NCT01879761` - Immune Resolution After Staphylococcus Aureus Bacteremia
Completed	`NCT01375621` - Livestock Contact and MRSA in Rural Areas
Recruiting	`NCT00532324` - Community-Acquired Methicillin Resistant Staphylococcus Aureus Colonization in Pregnant Women and Infections in Newborns	N/A
Completed	`NCT04503252` - Probability of Target Attainment With Standard Intermittent Bolus Administration of Cefazolin in Patients With Complicated Infections Caused by Staphylococcus Aureus
Recruiting	`NCT06368856` - Pharmacology of Mupirocin in Nasal Application in Healthy Volunteers: Monocentric Study	Phase 1
Not yet recruiting	`NCT05899140` - Adjunctive Clindamycin for the Treatment of Skin and Soft Tissue Infections, a Randomized Controlled Trial	Phase 4
Completed	`NCT01792804` - Staphylococcus Aureus Bacteremia Antibiotic Treatment Options	Phase 3
Enrolling by invitation	`NCT04897971` - Serum Based Diagnosis of and Monitoring of Infection Recovery in Orthopedic Spine Implant Infections