Experimental drug PMG1015 tested for lung scarring disease
NCT ID NCT05895565
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial tested an experimental drug called PMG1015 in 29 people with idiopathic pulmonary fibrosis (IPF), a lung-scarring disease. The main goal was to check the drug's safety and how the body processes it, not whether it works. Participants received either PMG1015 or a placebo, and researchers monitored side effects and lung function. Because this is a small, phase 1 study, results are preliminary and do not yet show if PMG1015 can treat IPF.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- PMG1015 (an experimental drug)
- What this could lead to
- If safe and effective, PMG1015 could offer a new treatment option to slow lung scarring in idiopathic pulmonary fibrosis.
- What could go wrong
- This is a very early, small phase 1b safety trial with only 29 participants. It is not designed to prove the drug works, and many early-stage drugs fail in later trials. Side effects are unknown.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
29 people
The number who actually took part.
- Started
-
May 2023
- Finished
-
Feb 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
40 to 85 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for IPF are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029, China
-
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210008, China
-
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030, China
-
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433, China
-
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510120, China
-
The Second Hospital of Anhui Medical University
Hefei, Anhui, 230000, China
-
Tongji Hospital Tongji Medical College of HUST
Wuhan, Hubei, 430030, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Sharper CT scans may solve a lung disease diagnostic puzzle
- Can a breath test predict lung scarring? new study seeks answers
- New inhaled drug for lung disease tested in healthy people first
- New hope for lung scarring: HSK44459 enters final trial phase
- Healthy volunteers to test experimental lung disease drug
- New drug for lung scarring takes first step in healthy volunteers