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UNKNOWNPHASE1

Study to Assess the Safety and Tolerability of ANG-3070 in Subjects With Idiopathic Pulmonary Fibrosis

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

NCT05387785•Angion Biomedica Corp

View on ClinicalTrials.gov

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.

Eligibility

Age

40 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. 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.
•2. Male or female subjects aged 40 years and older at the time of informed consent.
•3. 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.
•4. 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 Criteria

•1. Diagnosis of asthma or chronic obstructive pulmonary disease (COPD).
•2. Current tobacco use (quit at least 1 month prior to study for inclusion).
•3. Presence of active infection requiring ongoing therapy with systemic antibiotics and/or antivirals.
•4. Diagnosis of connective tissue disease.
•5. Known cause of ILD diagnosed.
•6. Active malignancy aside from local carcinoma.
•7. AST or ALT or total bilirubin \> 2x upper limit of normal (ULN).
•8. Pregnancy and/or lactation; positive serum beta human chorionic gonadotropin (β-HCG) during screening.

Key Dates

Start Date

June 1, 2022

Primary Completion Date

November 1, 2022

Completion Date

November 1, 2022

Last Updated

June 10, 2022

Enrollment

ESTIMATED participants

Conditions

Idiopathic Pulmonary Fibrosis (IPF)

Interventions

ANG-3070

DRUG

Placebo

DRUG

Contacts

Chantal Gosselin

CONTACT

857-378-4175 3070IPF@angion.com

Martin Robledo

CONTACT

3070IPF@angion.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 10, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study to Assess the Safety and Tolerability of ANG-3070 in Subjects With Idiopathic Pulmonary Fibrosis

Inclusion Criteria

Exclusion Criteria

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