A Multiple Ascending Doses (MAD) Study of PMG1015 in Idiopathic Pulmonary Fibrosis Subjects
NCT05895565 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 29
Last updated 2025-11-25
Summary
This is a phase 1b randomized, double-blind, placebo-controlled, multiple ascending doses (MAD) study of PMG1015 in idiopathic pulmonary fibrosis (IPF) subjects. This study aims to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of PMG1015 after MAD.
Conditions
Interventions
- DRUG
-
PMG1015
Including 3 dose levels: level 1, level 2 and level 3
- DRUG
-
PMG1015 placebo
Including 2 dose levels corresponding to PMG1015 level 1 and level 2, with no placebo group set for PMG1015 level 3
Sponsors & Collaborators
-
Pulmongene Ltd.
lead INDUSTRY
Principal Investigators
-
Wang · China-Japan Friendship Hospital
-
Dai · China-Japan Friendship Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-05-19
- Primary Completion
- 2025-02-07
- Completion
- 2025-02-07
Countries
- China
Study Locations
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