Testing PMG1015 for treating idiopathic pulmonary fibrosis

A Phase 1b, Multicenter, Randomized, Double-blind, Placebo-controlled Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PMG1015 in Idiopathic Pulmonary Fibrosis (IPF) Subjects

This study is testing a new drug called PMG1015 to see if it's safe and how well it works for people with idiopathic pulmonary fibrosis.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (estimated)
• Ages: 40 Years to 85 Years
• Sex: All
• Sponsor: Pulmongene Ltd. (Industry-sponsored)
• Locations: 7 sites (Hefei, Anhui and 6 other locations)
• Trial ID: NCT05895565 on ClinicalTrials.gov

What this trial studies

This phase 1b study evaluates the safety, tolerability, pharmacokinetics, and immunogenicity of PMG1015 in patients with idiopathic pulmonary fibrosis (IPF). It is a randomized, double-blind, placebo-controlled trial that involves multiple ascending doses of the drug. The study aims to determine how well PMG1015 is tolerated and its effects on patients with IPF. Participants will be monitored closely to assess the drug's impact and any potential side effects.

Who should consider this trial

Good fit: Ideal candidates are adults diagnosed with idiopathic pulmonary fibrosis who meet specific lung function criteria and are not currently on approved IPF treatments.

Not a fit: Patients with unstable IPF conditions or those likely to undergo lung transplantation within six months may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients suffering from idiopathic pulmonary fibrosis.

How similar studies have performed: While this approach is novel, similar studies targeting IPF have shown promise in evaluating new treatments.

Eligibility criteria

Key Inclusion Criteria:

1. Diagnosis of IPF as defined by current American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic Association (ALAT) Clinical Practice Guidelines for IPF (2022) (Pathological examination refers to transbronchial lung cryobiopsy or surgical/pleuroscopic lung biopsy);
2. Forced vital capacity percent predicted (FVCpp) ≥45% at screening;
3. Diffusing capacity of the lung for carbon monoxide (DLCO; corrected for haemoglobin) from 30% to 90% of the predicted, inclusive at screening;
4. Subjects not receiving any approved IPF treatment (pirfenidone or nintedanib) within 1 month before enrollment for any reasons

Key Exclusion Criteria:

1. Patients with instable condition of IPF as assessed by the investigator at screening, and those with acute exacerbation of IPF during screening or within 3 months prior to randomization;
2. Patients who are likely to be lung transplant recipients within 6 months or expected to survive less than 1 year as assessed by the investigator at screening;
3. Patients accompanying with an interstitial lung disease other than IPF;
4. Patients accompanying with other types of respiratory disorders, which may affect the study results as assessed by the investigator;
5. Patients who received vasodilator therapy for pulmonary arterial hypertension (e.g. Bosentan) within 1 month prior to screening;
6. Patients accompanying with other uncontrolled underlying diseases, for which the patient is not considered suitable for the study as assessed by the investigator;
7. Patients who had active tuberculosis within 12 months prior to screening, or clinical symptoms of bacterial, viral, fungal or microbial infections requiring intervention within 4 weeks prior to randomization;
8. Patients who have known allergic reaction to the investigational product or its active pharmaceutical ingredients (APIs), or history of allergic reaction to human, humanized, chimeric, or murine monoclonal antibodies or any substances contained in the excipients;
9. Pregnant or lactating women; female subjects who plan to become pregnant during the study, or patients who are not willing to take contraceptive measures as required by the protocol during the study;
10. Other conditions that preclude the patient from participating in the study as assessed by the investigator.

Where this trial is running

Hefei, Anhui and 6 other locations

• Site 07 — Hefei, Anhui, China (Recruiting)
• Site 01 — Beijing, Beijing, China (Recruiting)
• Site 06 — Guangzhou, Guangdong, China (Recruiting)
• Site 03 — Wuhan, Hubei, China (Recruiting)
• Site 04 — Nanjing, Jiangsu, China (Recruiting)
• Site 02 — Shanghai, Shanghai, China (Recruiting)
• Site 05 — Shanghai, Shanghai, China (Recruiting)

Study contacts

• Principal investigator: Wang — China-Japan Friendship Hospital
• Study coordinator: Wang

Conditions IPF