Healthy Volunteers, IPF
Conditions
Keywords
HW241045, healthy volunteers, Safety, Pharmacokinetics
Brief summary
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
DRUGHW241045
Dose 1 to Dose 7
DRUGPlacebo
Dose 1 to Dose 7
Sponsors
Hubei Bio-Pharmaceutical Industrial Technological Institute Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Key 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. Key
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The number and severity of treatment emergent adverse events (TEAEs) | Up to 48 hours | To assess the safety and tolerability of single oral dose of HW241045 in healthy adult volunteers |
Countries
China
Outcome results
None listed