Study of ORJ-001 for the Treatment of IPF

Part of paid clinical trials in Doral, Florida.

Sponsor
Oorja Bio, Inc.
Study ID
NCT07869147
Phase
PHASE2
Status
Recruiting
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Conditions

  • Idiopathic Pulmonary Fibrosis

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ORJ-001 — DRUG
    ORJ-001 is a peptide agonist of β1 integrin administered by subcutaneous injection twice weekly. In Part A, dose levels are 200 mg and 400 mg. In Part B, a single dose level selected from Part A will be evaluated.
  • Placebo — OTHER
    Matching placebo administered by subcutaneous injection twice weekly.

Study Details

ORJ-001 is a new class of drugs intended for the treatment of patients with idiopathic pulmonary fibrosis (IPF). This is a Phase 2 study in two parts; the objective of Part A will determine if ORJ-001 is well-tolerated by patients and how long the drug stays in the body. Part B will test how well the drug affects lung function. Animal models of IPF have shown that ORJ-001 can repair damaged lung tissue and improve markers of lung function.

Key Dates

First listed
Oct 9, 2026
Start date
Oct 31, 2026
Status verified
Oct 2026
Primary completion
Jan 31, 2029
Completion
Mar 31, 2029

Study Design

Enrollment
95 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A: ORJ-001 400 mg
    Participants receive ORJ-001 400 mg administered subcutaneously (SC) twice weekly (BIW) for 12 weeks. Randomization ratio: 3:1:1 (400 mg:200 mg:placebo).
  • Experimental: Part A: ORJ-001 200 mg
    Participants receive ORJ-001 200 mg administered subcutaneously (SC) twice weekly (BIW) for 12 weeks. Randomization ratio: 3:1:1 (active:active:placebo).
  • Placebo Comparator: Part A: Placebo
    Participants receive matching placebo administered subcutaneously (SC) twice weekly (BIW) for 12 weeks.
  • Experimental: Part B: ORJ-001 (Selected Dose)
    Participants receive the ORJ-001 dose selected based on Part A safety, tolerability, pharmacokinetic, pharmacodynamic, and efficacy data, administered subcutaneously (SC) twice weekly (BIW) for 12 weeks. Participants are randomized 1:1 to ORJ-001 or placebo.
  • Placebo Comparator: Part B: Placebo
    Participants receive matching placebo administered subcutaneously (SC) twice weekly (BIW) for 12 weeks.

Primary Outcome Measure

Part A: Safety and Tolerability of ORJ-001: Number of Participants with Treatment-Related Adverse Events (TEAEs) [ Time Frame: From first dose through Safety Follow-up Visit, up to 12 weeks. ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Innova Pharma Research, LLCDoralFlorida33172-
Clinical Research Associates of Central PADuBoisPennsylvania15801-

Find similar trials in Doral, FL

By research site
Innova Pharma Research, LLC· Doral, FLClinical Research Associates of Central PA· DuBois, PA

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