IPFPhase 1NCT05895565

A Multiple Ascending Doses (MAD) Study of PMG1015 in Idiopathic Pulmonary Fibrosis Subjects

A Phase 1 study testing PMG1015 in people with IPF, run by Pulmongene Ltd. at 7 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This is a phase 1b randomized, double-blind, placebo-controlled, multiple ascending doses (MAD) study of PMG1015 in idiopathic pulmonary fibrosis (IPF) subjects. This study aims to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of PMG1015 after MAD. Read more about this study

Who is it for?: Ages 40 to 85 years
Conditions the study is for: IPF
What is being tested?: PMG1015
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 29 participants
Where: 7 sitesChina
Study dates: 19 May 2023to 7 Feb 2025
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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);
Forced vital capacity percent predicted (FVCpp) ≥45% at screening;
Diffusing capacity of the lung for carbon monoxide (DLCO; corrected for haemoglobin) from 30% to 90% of the predicted, inclusive at screening;
Subjects not receiving any approved IPF treatment (pirfenidone or nintedanib) within 1 month before enrollment for any reasons

Who cannot join

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;
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;
Patients accompanying with an interstitial lung disease other than IPF;
Patients accompanying with other types of respiratory disorders, which may affect the study results as assessed by the investigator;
Patients who received vasodilator therapy for pulmonary arterial hypertension (e.g. Bosentan) within 1 month prior to screening;
Patients accompanying with other uncontrolled underlying diseases, for which the patient is not considered suitable for the study as assessed by the investigator;

Show all 10Show fewer

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;
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;
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;
Other conditions that preclude the patient from participating in the study as assessed by the investigator.

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

China7 sites

China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510120
The Second Hospital of Anhui Medical University
Hefei, Anhui, 230000
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210008
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433
Tongji Hospital Tongji Medical College of HUST
Wuhan, Hubei, 430030

Other trials in China

About this study

Official title: 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

Conditions: IPF
Being tested: PMG1015, PMG1015 placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PMG1015Drug
Including 3 dose levels: level 1, level 2 and level 3
PMG1015 placeboDrug
Including 2 dose levels corresponding to PMG1015 level 1 and level 2, with no placebo group set for PMG1015 level 3

Study groups in NCT05895565
Study group	Role	What they receive
PMG1015	Experimental	Not described Receives: Drug: PMG1015
Placebo Comparator	Placebo comparator	Not described Receives: Drug: PMG1015 placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

The incidence of treatment-emergent adverse events (TEAEs)
An Adverse Event (AE) is any event, side-effect or any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAEs are AEs that occur following the start of treatment.
Measured: Approximately 170 days.
The severity of treatment-emergent adverse events (TEAEs)
Severity of TEAEs (Grade 1 to 5) will be assessed based on NCI-CTCAE V5.0.
Measured: Approximately 170 days.
The incidence of serious adverse events (SAEs)
A serious adverse event (SAE) is defined as an AE occurring during any study phase and at any dose of medicinal product that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, or results in congenital anomaly/birth defect.
Measured: Approximately 170 days.
The severity of serious adverse events (SAEs)
A serious adverse event (SAE) is defined as an AE occurring during any study phase and at any dose of medicinal product that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, or results in congenital anomaly/birth defect.
Measured: Approximately 170 days.
Assessment of pulmonary function test results-forced vital capacity (FVC)
Pulmonary function test is a test to explore the functional status of human respiratory system with the knowledge of exercise respiratory physiology and modern examination technology. Forced vital capacity (FVC) (mL) will be measured at Visits 1, 8, 14 and 16, to assess the changes in FVC from baseline to post-dose.
Measured: Approximately 170 days.
Assessment of pulmonary function test results-forced vital capacity percent predicted (FVCpp)
Pulmonary function test is a test to explore the functional status of human respiratory system with the knowledge of exercise respiratory physiology and modern examination technology. Forced vital capacity percent predicted (FVCpp) (%) will be measured at Visits 1, 8, 14 and 16, to assess the changes in FVCpp from baseline to post-dose.
Measured: Approximately 170 days.
Assessment of pulmonary function test results-forced expiratory volume in 1 second (FEV1)
Pulmonary function test is a test to explore the functional status of human respiratory system with the knowledge of exercise respiratory physiology and modern examination technology. Forced expiratory volume in 1 second (FEV1) (L) will be measured at Visits 1, 8, 14 and 16, to assess the changes in FEV1 from baseline to post-dose.
Measured: Approximately 170 days.
Assessment of pulmonary function test results-diffusing capacity of the lungs for carbon monoxide (DLCO)
Pulmonary function test is a test to explore the functional status of human respiratory system with the knowledge of exercise respiratory physiology and modern examination technology. Diffusing capacity of the lungs for carbon monoxide (DLCO) (mL/min/mmHg) will be measured at Visits 1, 8, 14 and 16, to assess the changes in DLCO from baseline to post-dose.
Measured: Approximately 170 days.
Assessment of pulmonary function test results-diffusing capacity of the lungs for carbon monoxide percent predicted (DLCOpp)
Pulmonary function test is a test to explore the functional status of human respiratory system with the knowledge of exercise respiratory physiology and modern examination technology. Diffusing capacity of the lungs for carbon monoxide percent predicted (DLCOpp) (DLCO%) will be measured at Visits 1, 8, 14 and 16, to assess the changes in DLCOpp from baseline to post-dose.
Measured: Approximately 170 days.

Secondary outcomes (11)

Evaluate the area under the serum drug concentration-time curve from time zero to the last quantifiable time point (AUC0-t) of PMG1015.
AUC is a pharmacokinetic parameter that represents the concentration of a drug in the blood at a certain time.
Measured: Approximately 170 days.
Evaluate the area under the serum drug concentration-time curve from time zero to infinity (AUC0-∞) of PMG1015.
AUC is a pharmacokinetic parameter that represents the concentration of a drug in the blood at a certain time.
Measured: Approximately 170 days.
Evaluate the area under the concentration-time curve from time zero to the end of a dosing interval (AUC0-tau) of PMG1015.
AUC is a pharmacokinetic parameter that represents the concentration of a drug in the blood at a certain time.
Measured: Approximately 170 days.
Evaluate the maximum concentration (Cmax) of PMG1015.
Cmax refers to the highest concentration of a drug in the blood after administration, which is related to the dose, route of administration, dosing frequency, and time to reach the peak concentration.
Measured: Approximately 170 days.
Evaluate the time to reach the maximum concentration (Tmax) of PMG1015.
Tmax refers to the time when a drug reaches its maximum concentration and exhibits its maximum effect in the body.
Measured: Approximately 170 days.
Evaluate the half-life (t1/2) of PMG1015.
t1/2 refers to the time required for the drug concentration in the blood to decrease by half.
Measured: Approximately 170 days.
Evaluate the clearance rate (CL) of PMG1015.
CL is the volume of blood that is completely cleared of a drug per unit time by the excretory organs, and its unit is usually mL·(min·kg)-1 or L·(h·kg)-1.
Measured: Approximately 170 days.
Evaluate the distribution volume (Vz) of PMG1015.
Vz is a pharmacokinetic parameter that reflects the extent of drug distribution in various tissues in the body.
Measured: Approximately 170 days.
Evaluate the elimination rate constant (λz) of PMG1015.
λz is referred to as the elimination rate constant, which is defined as the ratio of the amount of compound eliminated per unit time to the total amount, with its unit being the reciprocal of time.
Measured: Approximately 170 days.
Correlation between the dose and exposure.
Dose refers to the quantity of drug administered at one time to achieve the desired therapeutic effect, and it can vary depending on the patient's needs and medical condition.
Measured: Approximately 170 days.
Incidence of PMG1015-induced and PMG1015-boosted ADAs.
Immunogenicity assessment is mainly based on anti-drug antibodies (ADAs), including the incidence of PMG1015-induced and PMG1015-boosted ADAs.
Measured: Approximately 170 days.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 May 20237 Feb 2025

First posted8 Jun 2023
Study start19 May 2023
Primary completion7 Feb 2025
Study completion7 Feb 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for IPFStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 29 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05895565
Sponsor's protocol ID: PMG1015_CHN_Ib
Status last verified: Nov 2025
First submitted: 11 Apr 2023
Last updated: 25 Nov 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingObservational study
Clinical and Basic Investigations Into Hermansky-Pudlak Syndrome
Hermansky-Pudlak Syndrome (HPS)
RecruitingPhase 2
An Extension Study of Subjects Who Received an Avalyn Inhaled Antifibrotic Agent (SAIL)
Progressive Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis (IPF)

All IPF trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT05895565
Acronym / sponsor ID: PMG1015_CHN_Ib
Conditions: IPF
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 29 participants (actual)
Lead sponsor: Pulmongene Ltd.Industry (pharma, biotech, devices)
Study start: 19 May 2023 (actual)
Primary completion: 7 Feb 2025 (actual)
Study completion: 7 Feb 2025 (actual)
First posted: 8 Jun 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
PMG1015	Experimental	Drug: PMG1015
Placebo Comparator	Placebo comparator	Drug: PMG1015 placebo

Who may qualify

Ages: 40 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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);
Forced vital capacity percent predicted (FVCpp) ≥45% at screening;
Diffusing capacity of the lung for carbon monoxide (DLCO; corrected for haemoglobin) from 30% to 90% of the predicted, inclusive at screening;
Subjects not receiving any approved IPF treatment (pirfenidone or nintedanib) within 1 month before enrollment for any reasons

Key exclusion criteria (10 listed)

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;
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;
Patients accompanying with an interstitial lung disease other than IPF;
Patients accompanying with other types of respiratory disorders, which may affect the study results as assessed by the investigator;
Patients who received vasodilator therapy for pulmonary arterial hypertension (e.g. Bosentan) within 1 month prior to screening;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PMG1015Including 3 dose levels: level 1, level 2 and level 3	Drug	PMG1015
PMG1015 placeboIncluding 2 dose levels corresponding to PMG1015 level 1 and level 2, with no placebo group set for PMG1015 level 3	Drug	Placebo Comparator

Primary outcome

The incidence of treatment-emergent adverse events (TEAEs)
Time frame: Approximately 170 days.
An Adverse Event (AE) is any event, side-effect or any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAEs are AEs that occur following the start of treatment.
The severity of treatment-emergent adverse events (TEAEs)
Time frame: Approximately 170 days.
Severity of TEAEs (Grade 1 to 5) will be assessed based on NCI-CTCAE V5.0.
The incidence of serious adverse events (SAEs)
Time frame: Approximately 170 days.
A serious adverse event (SAE) is defined as an AE occurring during any study phase and at any dose of medicinal product that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, or results in congenital anomaly/birth defect.
The severity of serious adverse events (SAEs)
Time frame: Approximately 170 days.
A serious adverse event (SAE) is defined as an AE occurring during any study phase and at any dose of medicinal product that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, or results in congenital anomaly/birth defect.
Assessment of pulmonary function test results-forced vital capacity (FVC)
Time frame: Approximately 170 days.
Pulmonary function test is a test to explore the functional status of human respiratory system with the knowledge of exercise respiratory physiology and modern examination technology. Forced vital capacity (FVC) (mL) will be measured at Visits 1, 8, 14 and 16, to assess the changes in FVC from baseline to post-dose.
Assessment of pulmonary function test results-forced vital capacity percent predicted (FVCpp)
Time frame: Approximately 170 days.
Pulmonary function test is a test to explore the functional status of human respiratory system with the knowledge of exercise respiratory physiology and modern examination technology. Forced vital capacity percent predicted (FVCpp) (%) will be measured at Visits 1, 8, 14 and 16, to assess the changes in FVCpp from baseline to post-dose.
Assessment of pulmonary function test results-forced expiratory volume in 1 second (FEV1)
Time frame: Approximately 170 days.
Pulmonary function test is a test to explore the functional status of human respiratory system with the knowledge of exercise respiratory physiology and modern examination technology. Forced expiratory volume in 1 second (FEV1) (L) will be measured at Visits 1, 8, 14 and 16, to assess the changes in FEV1 from baseline to post-dose.
Assessment of pulmonary function test results-diffusing capacity of the lungs for carbon monoxide (DLCO)
Time frame: Approximately 170 days.
Pulmonary function test is a test to explore the functional status of human respiratory system with the knowledge of exercise respiratory physiology and modern examination technology. Diffusing capacity of the lungs for carbon monoxide (DLCO) (mL/min/mmHg) will be measured at Visits 1, 8, 14 and 16, to assess the changes in DLCO from baseline to post-dose.
Assessment of pulmonary function test results-diffusing capacity of the lungs for carbon monoxide percent predicted (DLCOpp)
Time frame: Approximately 170 days.
Pulmonary function test is a test to explore the functional status of human respiratory system with the knowledge of exercise respiratory physiology and modern examination technology. Diffusing capacity of the lungs for carbon monoxide percent predicted (DLCOpp) (DLCO%) will be measured at Visits 1, 8, 14 and 16, to assess the changes in DLCOpp from baseline to post-dose.

11 secondary outcomes

Evaluate the area under the serum drug concentration-time curve from time zero to the last quantifiable time point (AUC0-t) of PMG1015.
Time frame: Approximately 170 days.
Evaluate the area under the serum drug concentration-time curve from time zero to infinity (AUC0-∞) of PMG1015.
Time frame: Approximately 170 days.
Evaluate the area under the concentration-time curve from time zero to the end of a dosing interval (AUC0-tau) of PMG1015.
Time frame: Approximately 170 days.
Evaluate the maximum concentration (Cmax) of PMG1015.
Time frame: Approximately 170 days.
Evaluate the time to reach the maximum concentration (Tmax) of PMG1015.
Time frame: Approximately 170 days.
Evaluate the half-life (t1/2) of PMG1015.
Time frame: Approximately 170 days.
Evaluate the clearance rate (CL) of PMG1015.
Time frame: Approximately 170 days.
Evaluate the distribution volume (Vz) of PMG1015.
Time frame: Approximately 170 days.
Evaluate the elimination rate constant (λz) of PMG1015.
Time frame: Approximately 170 days.
Correlation between the dose and exposure.
Time frame: Approximately 170 days.
Incidence of PMG1015-induced and PMG1015-boosted ADAs.
Time frame: Approximately 170 days.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
Individual participant dataSharing planned: No

Related trials for IPF

RecruitingPhase 2
Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingObservational study
Clinical and Basic Investigations Into Hermansky-Pudlak Syndrome
Hermansky-Pudlak Syndrome (HPS)
RecruitingPhase 2
An Extension Study of Subjects Who Received an Avalyn Inhaled Antifibrotic Agent (SAIL)
Progressive Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis (IPF)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Wang principal investigator

China-Japan Friendship Hospital

Dai principal investigator

China-Japan Friendship Hospital

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PMG1015 in people with IPF, run by Pulmongene Ltd. at 7 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence of treatment-emergent adverse events (TEAEs) (time frame: Approximately 170 days.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05895565.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.