TX000045 for Pulmonary Hypertension Due to Interstitial Lung Disease

Not yet recruiting at 5 trial locations

Overseen By Clinical Trials

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Tectonic Operating Company, Inc.

Must not be taking: Phosphodiesterase inhibitors, Endothelin antagonists

Disqualifiers: Pulmonary hypertension WHO Group 1, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

The primary purpose of this study is to assess the effect of TX000045 on pulmonary vascular resistance (PVR) in participants with pulmonary hypertension secondary to interstitial lung disease (PH-ILD) and to assess the safety and tolerability of TX000045 in participants with PH-ILD.

Are You a Good Fit for This Trial?

Inclusion Criteria

* 40% predicted less than or equal to (\<=) forced vital capacity (FVC) \<= 80% predicted at screening

I have been diagnosed with fibrotic lung disease on a chest CT in the past year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive subcutaneous injection of TX000045 at a dose of 300 mg every 4 weeks from Week 1 up to Week 13

16 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• TX000045

How Is the Trial Designed?

Group I: TX000045 300 mg Experimental Treatment 1 Intervention

Participants will receive subcutaneous (SC) injection of TX000045 at a dose of 300 milligrams (mg) every 4 weeks (Q4W) from Week 1 up to Week 13.

Who Is Running the Clinical Trial?

Tectonic Operating Company, Inc.

Lead Sponsor