Status:
UNKNOWN
Study to Assess the Safety and Tolerability of ANG-3070 in Subjects With Idiopathic Pulmonary Fibrosis
Lead Sponsor:
Angion Biomedica Corp
Conditions:
Idiopathic Pulmonary Fibrosis (IPF)
Eligibility:
All Genders
40+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to assess safety and tolerability of once daily (QD) and twice daily (BID) dosing of ANG-3070 in subjects with idiopathic pulmonary fibrosis (IPF) who are treatment-naïve,...
Eligibility Criteria
Inclusion
- Subject must be willing and of sufficient mental capacity to give written informed consent and comprehend the importance of adhering to study treatment and requirements.
- Male or female subjects aged 40 years and older at the time of informed consent.
- Substantiated diagnosis of IPF based on clinical, radiological, and/or pathologic data to the exclusion of alternate diagnoses that would contribute to extant interstitial lung disease (ILD) based on the opinion of the subject's physician using current diagnostic criteria.
- Subject:
- Is naïve to therapy with nintedanib or pirfenidone OR
- Refuses therapy with nintedanib or pirfenidone OR
- Had nintedanib or pirfenidone discontinued due to any reason, 4-week washout required
Exclusion
- Diagnosis of asthma or chronic obstructive pulmonary disease (COPD).
- Current tobacco use (quit at least 1 month prior to study for inclusion).
- Presence of active infection requiring ongoing therapy with systemic antibiotics and/or antivirals.
- Diagnosis of connective tissue disease.
- Known cause of ILD diagnosed.
- Active malignancy aside from local carcinoma.
- AST or ALT or total bilirubin \> 2x upper limit of normal (ULN).
- Pregnancy and/or lactation; positive serum beta human chorionic gonadotropin (β-HCG) during screening.
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05387785
Start Date
June 1 2022
End Date
November 1 2022
Last Update
June 10 2022
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