Tolerability, Pharmacokinetics and Efficacy of ZSP1603 in Patients With Idiopathic Pulmonary Fibrosis （IPF）

Guangdong Raynovent Biotech

Status and phase: Completed; Phase 2; Phase 1

Conditions: Idiopathic Pulmonary Fibrosis (IPF)

Treatments: Drug: ZSP1603; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05119972

ZSP1603-20-02

Details and patient eligibility

About

This study was divided into two parts. The first part was a dose escalation study: a open label dose escalation design was used to evaluate the safety, tolerance and pharmacokinetic characteristics of ZSP1603 in IPF patients. The second part was a randomized double-blind placebo-controlled design was used to preliminatively investigate the efficacy and safety of ZSP1603 in the treatment of IPF at the target dose.

Enrollment: 15 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• IPF diagnosed, according to 2018 American Thoracic Society (ATS), European Respiratory Society (ERS), Japanese Respiratory Society (JRS), Latin American Thoracic Association (ALAT) IPF guideline for diagnosis and management;
• Dlco (corrected for Hb): 30%-79% predicted of normal;
• FVC>= 50% predicted of normal;

Exclusion criteria

• FEV1/FVC< 0.7;
• PaO2 in resting state without oxygen inhalation < 50mmHg;
• Subjects who were likely to be lung transplant recipients or expected to survive less than 1 year during the study period as assessed by the investigator;
• Poorly controlled cardiovascular and cerebrovascular diseases;
• Patients who had used nidanib, pirfenidone, interferon, n-acetylcysteine, azathioprine, cyclophosphamide, cyclosporine, prednisone > 15mg/ day (or equivalent dose of other glucocorticoids) within 4 weeks before enrollment; Those who had used Chinese herbal medicine or acupuncture treatment within 1 week before enrollment;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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15 participants in 5 patient groups, including a placebo group

part1:ZSP1603 dose1

Experimental group

Treatment:

Drug: ZSP1603

part1:ZSP1603 dose2

Experimental group

Treatment:

Drug: ZSP1603

part1:ZSP1603 dose3

Experimental group

Treatment:

Drug: ZSP1603

Part2: ZSP1603 dose

Experimental group

Treatment:

Drug: ZSP1603

Part2: placebo

Placebo Comparator group

Treatment:

Drug: Placebo