A Phase I Study of HW241045 in Healthy Subjects
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HW241045 Formulation A, HW241045 Formulation B, Placebo.
- Who it may be relevant to
- Registry conditions: Idiopathic Pulmonary Fibrosis (IPF). Basic parameters: 18 years — 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of HW241045 Tablets After Single and Multiple Dosing in Healthy Study Participants.
Overview
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.
Interventions
- Drug HW241045 Formulation A
Single-dose administration in Part A. - Drug HW241045 Formulation B
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. - Drug Placebo
Single-dose administration in Part B, with 4 dose groups；Multiple-dose administration in Part C, with 3 dose groups.
Primary outcome measures
- The number and severity of treatment emergent adverse events (TEAEs) [Time frame: From the first dose administration to 48 hours after the last dose.]
Eligibility criteria
Inclusion criteria
- The study participant is able to communicate well with the investigator, understand and comply with all requirements of the study, fully comprehend the purpose, nature and methodology of the trial as well as potential adverse reactions, and sign the informed consent form prior to initiation of any study procedures.
- Healthy male and female study participants aged 18 to 45 years (inclusive).
- Female study participants shall have a body weight ≥ 45 kg, male study participants ≥ 50 kg; body mass index (BMI) ranges from 19 to 26 kg/m² (inclusive).
Exclusion criteria
- Any study participant with a past or current clinically severe or chronic disease involving the circulatory, endocrine, nervous, digestive, respiratory, hematologic, or immune system, as well as psychiatric disorders and metabolic abnormalities; or with any other disease deemed by the investigator likely to interfere with the trial results.
- Participants with a history of gastrointestinal, hepatic or renal diseases that may affect drug absorption or metabolism, or with known or suspected diseases that may interfere with drug intake, transportation, absorption, distribution, metabolism or excretion.
- Participants with a history of drug or food allergy, allergic diseases, or allergic constitution (allergic to two or more substances), or with a confirmed allergy to any component of the study drug.
- Participants who have used any drugs that inhibit or induce hepatic drug metabolism within 30 days prior to the trial or during the trial period.
- Participants with any other factors deemed unsuitable for participation in the clinical study by the investigator.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- The First Affiliated Hospital of Shandong First Medical University(Shandong Provincial Qia — Jinan
Identifiers
NCT: NCT07593690 · HW241045-102