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

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05387785

Enrollment

Registered

2022-05-24

Start date

2022-06-30

Completion date

2022-11-30

Last updated

2022-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Pulmonary Fibrosis (IPF)

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.

Interventions

DRUGANG-3070

Orally administered tyrosine kinase inhibitor capsule.

DRUGPlacebo

Orally administered placebo capsule

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Intervention model description

Multicenter, randomized, double-blind, placebo-controlled, cross-over design

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Change from baseline of the frequency and severity of treatment-emergent adverse events (TEAEs), including clinically significant abnormal findings from vital signs.	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).	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.	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.	Period 1 Day 1 and Period 2 Day 1

Contacts

Primary ContactChantal Gosselin

3070IPF@angion.com857-378-4175

Backup ContactMartin Robledo

3070IPF@angion.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026