NCT04643769

Evaluation of Oral ORIN1001 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)

Suspended Phase 1 Last updated 30 May 2025

What this trial tests

Phase 1 trial testing ORIN1001 in Idiopathic Pulmonary Fibrosis in 24 participants. Suspended.

Timeline

9 February 2021

Primary endpoint
30 December 2025

30 December 2025

Quick facts

Lead sponsor	Orinove, Inc.
Phase	Phase 1
Status	Suspended
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	triple
Primary purpose	treatment
Enrollment	24
Start date	9 February 2021
Primary completion	30 December 2025
Estimated completion	30 December 2025
Sites	11 locations across United States

Drugs / interventions tested

• ORIN1001 — full drug profile →
• Placebo

Conditions studied

• Idiopathic Pulmonary Fibrosis — all drugs for Idiopathic Pulmonary Fibrosis →

Sponsor

Orinove, Inc. — full company profile →

Who can join

Adults 40 to 80, any sex, with Idiopathic Pulmonary Fibrosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This Phase 1b trial is a double-blind, placebo-controlled, multiple ascending dose study to evaluate the safety and tolerability of oral ORIN1001 at 25 mg, 50 mg or 100 mg administered daily for up to 28 days in adult subjects with idiopathic pulmonary fibrosis (IPF) alone or in conjunction with local Standard of Care for IPF (pirfenidone or nintedanib).

A maximum of 24 evaluable subjects will be required to complete the study. The study will consist of 3 dose cohorts each enrolling a maximum of 8 subjects randomized either to the active (5 subjects) group or placebo (3 subjects) group. Each subject will receive daily oral doses of ORIN1001 or placebo for 28 days.

The safety and pharmacokinetic profile will be evaluated in this study and will include cardiovascular and pulmonary endpoints.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Pulmonary fibrosis from molecular mechanisms to therapeutic interventions: lessons from post-COVID-19 patients.
   Giacomelli C, Piccarducci R, Marchetti L, Romei C, et al · · 2021 · cited 48× · PMID 34687672 · DOI 10.1016/j.bcp.2021.114812
2. Research Progress in the Molecular Mechanisms, Therapeutic Targets, and Drug Development of Idiopathic Pulmonary Fibrosis.
   Ma H, Wu X, Li Y, Xia Y. · · 2022 · cited 47× · PMID 35935869 · DOI 10.3389/fphar.2022.963054
3. Progress in understanding and treating idiopathic pulmonary fibrosis: recent insights and emerging therapies.
   Guo H, Sun J, Zhang S, Nie Y, et al · · 2023 · cited 23× · PMID 37608885 · DOI 10.3389/fphar.2023.1205948
4. Inflammatory ER stress responses dictate the immunopathogenic progression of systemic candidiasis.
   Awasthi D, Chopra S, Cho BA, Emmanuelli A, et al · · 2023 · cited 16× · PMID 37432737 · DOI 10.1172/jci167359
5. Beyond UPR: cell-specific roles of ER stress sensor IRE1α in kidney ischemic injury and transplant rejection.
   Qiu L, Zheng X, Jaishankar D, Green R, et al · · 2023 · cited 15× · PMID 37391039 · DOI 10.1016/j.kint.2023.06.016
6. COVID-19 and fibrosis: Mechanisms, clinical relevance, and future perspectives.
   Saifi MA, Bansod S, Godugu C. · · 2022 · cited 12× · PMID 36075378 · DOI 10.1016/j.drudis.2022.103345
7. Emerging Concepts in Therapeutic Interventions for Idiopathic Pulmonary Fibrosis.
   Schott CA, Mohning MP, Cooley JC. · · 2025 · cited 1× · PMID 40633816 · DOI 10.1055/a-2651-1937