Trials / Withdrawn
WithdrawnNCT05349760
A Phase 2 Study to Evaluate Safety and Efficacy of AMB-05X in Subjects With Idiopathic Pulmonary Fibrosis
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of AMB-05X in Subjects With Idiopathic Pulmonary Fibrosis
- Status
- Withdrawn
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- AmMax Bio, Inc. · Industry
- Sex
- All
- Age
- 40 Years
- Healthy volunteers
- Not accepted
Summary
AMB-053-01 is a randomized, placebo controlled, multicenter study which will enroll approximately 36 subjects ages 40 and older with IPF for 6 doses over a 24-week dosing period.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | AMB-05X | A fully human monoclonal immunoglobulin (IgG2) directed against c-fms |
| DRUG | Placebo | Saline/D5W |
Timeline
- Start date
- 2023-03-01
- Primary completion
- 2025-03-01
- Completion
- 2025-06-01
- First posted
- 2022-04-27
- Last updated
- 2023-01-19
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05349760. Inclusion in this directory is not an endorsement.