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

Part of paid clinical trials in Clearwater, Florida.

Sponsor
Orinove, Inc.
Study ID
NCT04643769
Phase
PHASE1
Status
Suspended

Conditions

  • Idiopathic Pulmonary Fibrosis

Eligibility Criteria

Sex
ALL
Age
40 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • ORIN1001 — DRUG
    Oral tablet - ORIN1001
  • Placebo — DRUG
    Oral tablet - placebo

Study Details

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.

Key Dates

First listed
Nov 25, 2020
Start date
Feb 9, 2021
Status verified
May 2025
Primary completion
Dec 30, 2025
Completion
Dec 30, 2025

Study Design

Enrollment
24 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: 25 mg ORIN1001 (Active)
    25 mg ORIN1001
  • Experimental: 50 mg ORIN1001 (active)
    50 mg ORIN1001
  • Experimental: 100 mg ORIN1001 (active)
    100 mg ORIN1001
  • Placebo Comparator: Placebo - 25 mg
    Placebo comparator for ORIN1001 at 25 mg
  • Placebo Comparator: Placebo - 50 mg
    Placebo comparator for ORIN1001 at 50 mg
  • Placebo Comparator: Placebo - 100 mg
    Placebo comparator for ORIN1001 at 100 mg

Primary Outcome Measure

Blood pressure [ Time Frame: Up to 60 days ]

Locations (11)

FacilityCityStateZIPSite coordinators
St. Francis Sleep, Allergy & Lung InstituteClearwaterFlorida33765-
Mayo Clinic HospitalJacksonvilleFlorida32224-
Avanza Medical ResearchPensacolaFlorida32503-
Coastal Pulmonary and Critical CareSt. PetersburgFlorida33704-
Loyola University Medical CenterMaywoodIllinois60153-
University of Iowa HospitalIowa CityIowa52242-
Infinity Medical ResearchNorth DartmouthMassachusetts02747-
Hannibal ClinicHannibalMissouri63401-
Dartmouth Hitchcock Medical CenterLebanonNew Hampshire03766-
Duke University HospitalDurhamNorth Carolina27710-
University of CincinnatiCincinnatiOhio45220-

Find similar trials in Clearwater, FL

By research site
St. Francis Sleep, Allergy & Lung Institute· Clearwater, FLMayo Clinic Hospital· Jacksonville, FLAvanza Medical Research· Pensacola, FLCoastal Pulmonary and Critical Care· St. Petersburg, FLLoyola University Medical Center· Maywood, ILUniversity of Iowa Hospital· Iowa City, IA

Related Studies