Recruiting
Phase 2

TX000045

Sponsor:

Tectonic Operating Company, Inc.

Code:

NCT07473700

Conditions

Hypertension, Pulmonary

Lung Diseases, Interstitial

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

TX000045

Study Details

Brief summary:

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.

Conditions

Hypertension, Pulmonary

Lung Diseases, Interstitial

Study ID

NCT07473700

Start date

Oct, 2026

Status verified date

Sep, 2026

Completion date

Dec 11, 2027

Anticipated

Primary completion date

Nov 21, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Confirmed diagnosis of ILD based on imaging: chest computed tomography (CT) performed within the past 12 months with fibrotic lung disease (greater than or equal to (>=) 10 percent (%) lung parenchyma with fibrosis) consistent with idiopathic interstitial pneumonia, ILD in association with connective tissue disease, occupational ILD, or chronic hypersensitivity pneumonitis. Chest CTs will be centrally read for eligibility
  • 40% predicted less than or equal to (<=) forced vital capacity (FVC) <= 80% predicted at screening
  • At least ONE of the following is required to undergo the first screening visit: Documented diagnostic right heart catheterization (RHC) within 18 months of screening with mean pulmonary arterial pressure (mPAP) >= 25 millimeters of mercury (mm Hg), pulmonary capillary wedge pressure (PCWP) <=15 mm Hg, and pulmonary vascular resistance (PVR) >=4 Wood units; Documented echocardiogram (ECHO) within 18 months of screening with right ventricular (RV) (or pulmonary artery) systolic pressure >46 mm Hg or tricuspid annular plane systolic excursion (TAPSE)/ systolic pulmonary artery pressure (SPAP) <=0.38 and absence of clinically significant left ventricular dysfunction as assessed by the investigator

Exclusion Criteria:

  • Participants have a confirmed or suspected diagnosis of pulmonary hypertension in World Health Organization (WHO) Group 1, WHO Group 2, WHO Group 4, or WHO Group 5
  • Participants have received phosphodiesterase type 5 inhibitors, endothelin receptor antagonists, soluble guanylate cyclase stimulators, intravenous (IV) or subcutaneous (SC) prostacyclin analogues within 30 days before the first screening visit, or sotatercept within 180 days before the first screening visit
  • Participants have any type of pulmonary and cardiovascular comorbidities as defined n protocol
  • Participants who are taking disease-modifying therapy for the underlying interstitial lung disease (ILD) (anti-fibrotics, immunosuppressives, and anti-inflammatory medications) who are not on stable doses for >30 days before the first screening visit or have initiated new ILD-directed therapies within 90 days before the first screening visit

Study Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: TX000045 300 mg

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.

Interventions

TX000045

Subcutaneous Injection.

Primary outcome measure

  • Mean Change from Baseline in PVR up to 16 Weeks [ Time Frame: Baseline up to 16 weeks ]
  • Number of Participants with Adverse Events (AEs), Adverse Events of Special Interest (AESIs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to 21 weeks ]
  • Number of Participants with Clinically Significant Changes from Baseline in Safety Laboratory Assessments, 12-Lead Electrocardiogram (ECG) Assessments and Vital Sign Assessments [ Time Frame: Baseline up to 21 weeks ]

Central Contacts and Locations

Central contacts

Clinical Trials

+1 339 337 4053ClinicalTrials@tectonictx.com

Locations

Phoenix

Recruiting

Phoenix, Arizona, United States, 85020

San Francisco

Recruiting

San Francisco, California, United States, 94143

More Information

Sponsor

Tectonic Operating Company, Inc.

Last update posted

Sep 8, 2026

Last verified

Sep, 2026

Keywords

  • Interstitial lung disease
  • pulmonary vascular resistance

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Tectonic Operating Company, Inc. on 2026-09-08.