LTI-03 for Idiopathic Pulmonary Fibrosis

Recruiting at 7 trial locations

Overseen By Sydney Kruger, MS

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Rein Therapeutics

Must not be taking: Antifibrotics, N-acetyl cysteine

Disqualifiers: Asthma, Obstructive lung disease, others

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

24 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial will test the safety and tolerability of an inhaled medication called LTI-03 in people who have been diagnosed with idiopathic pulmonary fibrosis (IPF) and have not yet received any treatment. The medication is inhaled directly into the lungs to see if it can help with the symptoms of IPF.

Research Team

Steven A. Shoemkaer, MD

Principal Investigator

Lung Therapeutics

Eligibility Criteria

This trial is for adults over 40 with newly diagnosed Idiopathic Pulmonary Fibrosis (IPF), confirmed by specific tests, who haven't been in other drug studies recently. They must have certain lung function levels and can't be severely ill or unable to use the inhaler. Women of childbearing age and men with partners must agree to contraception.

Inclusion Criteria

Your lung function test shows that your lungs can take in a certain amount of air, but not too much.

You are 40 years old or older.

You have been diagnosed with IPF within the past 3 years, confirmed by a special type of chest scan or a lung biopsy following specific medical guidelines.

Exclusion Criteria

Participation in a clinical study or treatment with an investigational drug or device within 30 days of the Screening Visit (or 5 half-lives of the investigational agent, whichever is longer)

Vaccination within 2 weeks of start of dosing (Day 1) and throughout the Treatment Period

You are unable to use the inhaler properly.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive LTI-03 or placebo by inhalation for 14 days using a dry-powder inhaler

2 weeks

Self-administered

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

Treatment Details

Interventions

• LTI-03

Trial Overview The study is testing LTI-03, an inhaled medication for IPF patients who haven't had treatment before. Participants will either receive LTI-03 or a placebo to check how safe it is and how well they tolerate it.

Participant Groups

Group I: 5 mg LTI-03 BID Experimental Treatment 1 Intervention

5 mg LTI-03 BID x 14 days

Group II: 2.5 mg LTI-03 BID Experimental Treatment 1 Intervention

2.5 mg LTI-03 BID x 14 days

Group III: Placebo Placebo Group 1 Intervention

Matching placebo BID x 14 days

Who Is Running the Clinical Trial?

Rein Therapeutics

Lead Sponsor

Lung Therapeutics, Inc

Lead Sponsor

Trials

3

Recruited

140+