A Multicenter, Randomized, Double-Blind, Placebo-Controlled, 2-Period, 2-Arm, 4-Sequence, Crossover Phase 1b Study to Assess the Safety, Tolerability, and Pharmacokinetics of Ang-3070 in Subjects With Idiopathic Pulmonary Fibrosis Who Are Treatment-Naïve or Who Have Failed or Refused Standard of Care Treatment
Overview
- Phase
- Phase 1
- Intervention
- ANG-3070
- Conditions
- Idiopathic Pulmonary Fibrosis (IPF)
- Sponsor
- Angion Biomedica Corp
- Enrollment
- 20
- Primary Endpoint
- Change from baseline of the frequency and severity of treatment-emergent adverse events (TEAEs), including clinically significant abnormal findings from vital signs.
- Last Updated
- 3 years ago
Overview
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, refused therapy, or discontinued for any reason current standard of care with nintedanib or pirfenidone.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
- •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 Criteria
- •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.
Arms & Interventions
500 mg QD
500 mg QD of ANG-3070 will be taken once a day for 10 days.
Intervention: ANG-3070
300 mg BID
300 mg BID of ANG-3070 will be taken twice a day for 10 days.
Intervention: ANG-3070
Placebo-to-match 500 mg QD
Placebo-to-match 500 mg QD of ANG-3070 will be taken once a day for 10 days.
Intervention: Placebo
Placebo-to-match 300 mg BID
Placebo-to-match 300 mg BID of ANG-3070 will be taken twice a day for 10 days.
Intervention: Placebo
Outcomes
Primary Outcomes
Change from baseline of the frequency and severity of treatment-emergent adverse events (TEAEs), including clinically significant abnormal findings from vital signs.
Time Frame: Period 1 Day 1 and Day 30
Change from baseline of the frequency and severity of treatment-emergent adverse events (TEAEs), including clinically significant abnormal findings from 12-lead electrocardiograms (ECGs).
Time Frame: Period 1 Day 1 and Day 30
Change from baseline of the frequency and severity of treatment-emergent adverse events (TEAEs), including clinically significant abnormal findings from laboratory test results.
Time Frame: Period 1 Day 1 and Day 30
Change from baseline of the frequency and severity of treatment-emergent adverse events (TEAEs), including clinically significant abnormal findings from physical examination.
Time Frame: Period 1 Day 1 and Period 2 Day 1