A Study to Evaluate the Safety, Tolerability and Pharmacokinetic Properties of 9MW3811 in Healthy Subjects
NCT05740475 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32
Last updated 2025-12-09
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.
Conditions
- Pulmonary Fibrosis
- Tumor
Interventions
- DRUG
-
9MW3811 injection
Single dose intravenously infused on day 1
- DRUG
-
Single dose of matching placebo intravenously infused on day 1
Sponsors & Collaborators
-
Mabwell (Shanghai) Bioscience Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-03-20
- Primary Completion
- 2023-09-14
- Completion
- 2024-01-06
Countries
- Australia
Study Locations
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