NCT05740475

A Study to Evaluate the Safety, Tolerability and Pharmacokinetic Properties of 9MW3811 in Healthy Subjects

A Phase 1, First-in-human, Randomized, Double-blind，Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetic, Pharmacodynamics and Immunogenicity of 9MW3811 in Healthy Adult Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a first-in-human, single ascending dose study of 9MW3811, the primary objective of which is to evaluate the safety and tolerability of 9MW3811 in healthy adult participants.

Detailed description

The single ascending dose study will comprise 4 dose cohorts of 8 healthy participants each. In each cohort, participants will be randomized to receive 9MW3811 or placebo by 6:2.

Conditions

• Pulmonary Fibrosis
• Tumor

Interventions

Type	Name	Description
DRUG	9MW3811 injection	Single dose intravenously infused on day 1
DRUG	Placebo	Single dose of matching placebo intravenously infused on day 1

Timeline

• Start date: 2023-03-20
• Primary completion: 2023-09-14
• Completion: 2024-01-06
• First posted: 2023-02-23
• Last updated: 2025-12-09

Locations

1 site across 1 country: Australia