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

A Multi-center, Phase Ib/IIa Clinical Trial to Evaluate the Tolerability, PK and Efficacy of ZSP1603 in Patients With Idiopathic Pulmonary Fibrosis

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05119972

Enrollment

Registered

2021-11-15

Start date

2021-10-21

Completion date

2023-12-21

Last updated

2025-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Pulmonary Fibrosis (IPF)

Brief summary

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.

Interventions

DRUGZSP1603

ZSP1603 administered orally

DRUGPlacebo

Placebo administered orally

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

The trial has two parts, a part 1 and a part 2, in part 1 will be unblinded

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

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;

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	up to 16 weeks	TEAEs will be summarized displaying the number of TEAEs along with the number and percentage of participants with at least one TEAE according to: Number of AEs, Severity and relation to study drug.
Plasma concentrations of ZSP1603	up to 15 Days	Pharmacokinetic analysis

Secondary

Measure	Time frame	Description
Change in FVC From Baseline at 12 weeks	up to 12 weeks	Change of Forced Vital Capacity (FVC) evaluated from baseline until 12 weeks of treatment.
Change in FVC%Pred from baseline at 12 weeks	up to12 weeks	Change of predicted Forced Vital Capacity (FVC) (% Predicted) evaluated from baseline until 12 weeks of treatment.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026