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Phase ll Study of HEC585 in Patients With IPF

Study Purpose

A Phase ll Study to evaluate the efficacy and safety of various doses of HEC585 Tablets in patients with idiopathic pulmonary fibrosis

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	40 Years - 80 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Volunteer to participate in this clinical study and sign the ICF before the study begins; - Aged 40-80 (including 40 and 80) ; - Female or male subjects with child-bearing potential who agree and promise to take effective contraceptive measures; - Diagnosed with IPF according to the Official ATS/ERS/JRS/ALAT Clinical Practice Guideline for IPF Diagnosis (2018); - FEV1/FVC ≥ 0.7; - FVC ≥ 45% predicted; - DLCO corrected for Haemoglobin (Hb) ≥ 30% predicted of normal; - In the opinion of the Investigator, subjects are willing and able to comply with the protocol requirements and attend the visit.

Exclusion Criteria:

- In the opinion of the Investigator, subjects underwent significant deterioration in IPF within one month before randomization; - Interstitial lung disease caused by other known causes; - Any bacterial, viral, parasitic or fungal infection that needs to be treated at screening; - Expected to receive lung transplantation during the study; - Expected survival is less than 6 months; - History of tumors within 5 years before screening (except for localized cancers such as basal cell carcinoma); - Moderate to severe hepatic insufficiency (Child-Pugh grade B or C, see Appendix 4); - History of unstable or worsening heart disease within 6 months before screening; - Cannot perform 6MWT or PFT; - Allergic to any component of HEC585 Tablets or pirfenidone tablets; - Participated in other clinical study and received the last dose within 3 months before screening; - Pregnant or breastfeeding; - History of smoking within 3 months before screening or are unwilling to quit smoking during the study; - Subjects often drink alcohol within 6 months before the screening (drink more than 21 units of alcohol a week), or refuse to reduce alcohol intake during the study; - History of drug abuse within 6 months before the screening; - Family or personal history of QT prolongation syndrome; - Any condition that, in the opinion of the investigator, would compromise the safety or compliance of the subject, or prevent the subject from completing the study.

- TBil > 1.5 × ULN or AST or ALT > 2 × ULN; - CLcr < 50 mL/min; - Human immunodeficiency virus (HIV) antibody is positive; - Uncontrolled hepatitis B virus infection or hepatitis C virus infection; - QTcF > 480 ms.

- Subjects have received any of the following treatments within 28 days before randomization: 1.

Any cytotoxic drug or immunosuppressant. 2. Therapeutic drugs for IPF, including but not limited to pirfenidone, nintedanib, prednisone at > 15 mg/d or other glucocorticoids of the equivalent dose, N-acetylcysteine at > 600 mg/d. 3. Moderate and strong inhibitor or strong inducer of CYP1A2. 4. Strong inducers or strong CYP3A4 inhibitors.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05060822
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Sunshine Lake Pharma Co., Ltd.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Idiopathic Pulmonary Fibrosis

Arms & Interventions

Arms

Experimental: HEC585 dose A

Drug: HEC585 dose A once daily, up to 24 weeks-120 weeks

Experimental: HEC585 dose B

Drug: HEC585 dose B once daily, up to 24 weeks-120 weeks

Experimental: HEC585 dose C

Drug: HEC585 dose C once daily, up to 24 weeks-120 weeks

Active Comparator: pirfenidone

Drug: pirfenidone three times a day (target dose), up to 24 weeks

Placebo Comparator: placebo

Drug: placebo once daily, up to 24 weeks-120 weeks

Interventions

Drug: - HEC585

HEC585 Tablets，once daily

Drug: - Pirfenidone

Pirfenidone，three times a day

Drug: - Placebo

Placebo，once daily

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.