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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| part1:ZSP1603 dose1 | Experimental |
| |
| part1:ZSP1603 dose2 | Experimental |
| |
| part1:ZSP1603 dose3 | Experimental |
| |
| Part2: ZSP1603 dose | Experimental |
| |
| Part2: placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZSP1603 | Drug | ZSP1603 administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | 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. | up to 16 weeks |
| Plasma concentrations of ZSP1603 | Pharmacokinetic analysis | up to 15 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in FVC From Baseline at 12 weeks | Change of Forced Vital Capacity (FVC) evaluated from baseline until 12 weeks of treatment. | up to 12 weeks |
| Change in FVC%Pred from baseline at 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Lung Hospital | Shanghai | Shanghai Municipality | 200433 | China |
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| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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The trial has two parts, a part 1 and a part 2, in part 1 will be unblinded
| Placebo | Drug | Placebo administered orally |
|
Change of predicted Forced Vital Capacity (FVC) (% Predicted) evaluated from baseline until 12 weeks of treatment.
| up to12 weeks |