NCT06389942

Single Ascending Dose Study of 9MW3011 in Chinese Healthy Subject

A Single-center, Randomized, Double-Blind, Placebo-Controlled Phase 1 Single Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity Characteristics of 9MW3011 in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The objectives of the study are to evaluate the safety , tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of single ascending intravenous (IV) doses of 9MW3011 in Chinese healthy volunteers.

Detailed description

The single ascending dose(SAD) study will comprise 6 dose cohorts of 8 healthy volunteers each. In each cohort, subjects will be randomized in a 6:2 ratio to receive 9MW3011 or placebo via intravenous infusion.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	9MW3011	Single dose intravenously on day 1
DRUG	9MW3011 placebo	Single dose intravenously on day 1

Timeline

• Start date: 2023-03-10
• Primary completion: 2024-05-31
• Completion: 2024-05-31
• First posted: 2024-04-29
• Last updated: 2024-12-27

Locations

1 site across 1 country: China