Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a Phase I, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and food effect (FE) of HW241045 in healthy participants.
This study consists of three parts:1)Part A: A single-dose, two-period, two-way crossover design to evaluate the safety and pharmacokinetic differences between Formulation A and Formulation B of HW241045 tablets; 2)Part B: A single-dose ascending dose design to evaluate the safety, tolerability, and pharmacokinetic profiles of HW241045 Formulation B following single administration. A food-effect study is nested within this part.3)Part C: A multiple-dose ascending dose design to evaluate the safety, tolerability, and pharmacokinetic profiles of HW241045 Formulation B after multiple administrations.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HW241045 Formulation A | Experimental |
| |
| HW241045 Formulation B | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HW241045 Formulation A | Drug | Single-dose administration in Part A. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The number and severity of treatment emergent adverse events (TEAEs) | To assess the safety and tolerability of single or multiple oral dose of HW241045 in healthy participants. | From the first dose administration to 48 hours after the last dose. |
Not provided
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Shandong First Medical University(Shandong Provincial Qianfoshan Hospital) | Jinan | Shandong | 250014 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| HW241045 Formulation B |
| Drug |
Single-dose administration in Part A;Single-dose administration in Part B, with 4 dose groups;Multiple-dose administration in Part C, with 3 dose groups. |
|
| Placebo | Drug | Single-dose administration in Part B, with 4 dose groups;Multiple-dose administration in Part C, with 3 dose groups. |
|