A Phase Ia Clinical Trial of HW241045
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, Placebo.
- Who it may be relevant to
- Registry conditions: Healthy Volunteers, IPF. Basic parameters: 18 years — 55 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 Phase Ia Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of HW241045 Tablets Following a Single Dose in Healthy Subjects: A Single-center, Randomized, Double-blind, Placebo-controlled Study
Overview
This is a Phase Ia, randomized, double-blind, placebo-controlled study to assess the safety, tolerability and pharmacokinetic (PK) of HW241045 in healthy subjects following a single ascending dose.
Interventions
- Drug HW241045
Dose 1 to Dose 7 - Drug Placebo
Dose 1 to Dose 7
Primary outcome measures
- The number and severity of treatment emergent adverse events (TEAEs) [Time frame: Up to 48 hours]
Eligibility criteria
Inclusion criteria
- The subjects have been fully informed of the trial's purpose, nature, methodology, and potential adverse reactions. They voluntarily participate in the trial and sign the informed consent form prior to the initiation of any study procedures;
- Healthy male and female subjects aged 18 to 55 years;
- Female subjects must have a body weight of ≥ 45 kg and male subjects ≥ 50 kg, with a body mass index (BMI) ranging from 19 to 26 kg/m².
Exclusion criteria
- Subjects with a history of or current severe clinical disease involving any of the following systems: circulatory, endocrine, nervous, digestive, respiratory, hematological, immune, mental, or metabolic systems; or subjects with any other disease that the investigator judges may interfere with the study results;
- Subjects with a history of severe trauma or major surgery within 3 months prior to screening; or subjects planning to undergo surgery during the trial period or within two weeks after study completion;
- Subjects with a history of gastrointestinal, hepatic, or renal diseases that affect drug absorption or metabolism; or those with conditions known or suspected to interfere with drug ingestion, transport, absorption, distribution, metabolism, or excretion;
- Subjects with clinically significant abnormalities in any screening test results as judged by the investigator;
- Subjects with a history of drug or food allergy, allergic disorders, or atopic diathesis; or those with confirmed hypersensitivity to any component of the investigational drug;
- Subjects with difficult venous blood collection, or whose physical condition cannot tolerate intensive blood sampling;
- Not suitable for this study as judged 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
- Peking Union Medical College Hospital — Beijing
Identifiers
NCT: NCT07448194 · RFIP-Ia-202507