A Multiple Ascending Doses (MAD) Study of PMG1015 in Idio... | NCT05895565

NCT05895565

Protocol Section

Identification Module

Results Section

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Annotation Section

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Document Section

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Derived Section

Miscellaneous Info Module

Status Module

Label	Type	Description	Intervention Names
PMG1015	Experimental		Drug: PMG1015
Placebo Comparator	Placebo Comparator		Drug: PMG1015 placebo

Name	Type	Description	Arm Group Labels	Other Names
PMG1015	Drug	Including 3 dose levels: level 1, level 2 and level 3	PMG1015

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	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.	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.	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.	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.

Secondary Outcomes

Measure	Description	Time Frame
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.	Approximately 170 days.
Evaluate the area under the serum drug concentration-time curve from time zero to infinity (AUC0-∞) of PMG1015.

Eligibility Module

Eligibility Criteria

Key Inclusion Criteria:

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:

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;
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.

Name	Affiliation	Role
Wang	China-Japan Friendship Hospital	Principal Investigator
Dai	China-Japan Friendship Hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
The Second Hospital of Anhui Medical University		Hefei	Anhui	230000	China
China-Japan Friendship Hospital