NCT05170243

A Clinical Study in Healthy Subjects to Evaluate 9MW1911 Injection

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics Characteristics and Immunogenicity of a Single Dose of 9MW1911 Injection in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 1, randomized, placebo-controlled study, enrolling approximately 38 healthy adult subjects (18-65 yrs). The purpose of this study is to evaluate the safety, tolerability and PK of single ascending dose of 9MW1911 administered intravenously (IV) in healthy adult volunteers. All subjects will be followed up for safety from the time of Informed Consent through 113 days post dose.

Conditions

• Asthma
• COPD
• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	9MW1911 Injection	Single dose intravenously on day 1
DRUG	9MW1911 Injection Placebo	Single dose of matching placebo intravenously on day 1

Timeline

• Start date: 2022-01-21
• Primary completion: 2022-07-03
• Completion: 2022-10-28
• First posted: 2021-12-27
• Last updated: 2023-12-11

Locations

1 site across 1 country: China