Menu
Not yet recruiting NCT07493031

A PhaseⅠ Study of HW252001 in Healthy Subjects

Phase I Interventional IPF

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: HW252001, Placebo.
Who it may be relevant to
Registry conditions: 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 I, Single-center, Randomized, Double-blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HW252001 Tablets After Single and Multiple Dosing in Healthy Subjects

Overview

This is a phase 1, randomized, double-blind, placebo-controlled, Single/multiple ascending doses (SAD/MAD) study of HW252001 in healthy subjects. This study aims to evaluate the safety, tolerability, pharmacokinetics and Pharmacodynamics of HW252001.

Interventions

  • Drug HW252001
    HW252001 will be administered as oral tablets at assigned dose levels within each cohort in Part 1 (SAD) and Part 2 (MAD).
  • Drug Placebo
    Placebo will be administered as oral tablets at assigned dose levels within each cohort in Part 1 (SAD) and Part 2 (MAD).

Primary outcome measures

  • The number and severity of treatment emergent adverse events (TEAEs) [Time frame: up to 11 days]
Secondary outcome measures (2)
  • Cmax [Time frame: up to 11 days]
  • Tmax [Time frame: up to 11 days]

Eligibility criteria

Inclusion criteria

  • The participant must sign informed consent prior to the trial, understand the trial's content, procedures, and potential adverse reactions, and be able to complete the study in accordance with the trial protocol requirements.
  • Healthy male or female subjects, aged ≥18 and ≤55 years on the day of signing the informed consent form.
  • During the screening period, male participants must weigh ≥50 kg, and female participants must weigh ≥45 kg. Body Mass Index (BMI) = weight (kg) / height² (m²), and must be within the range of 19 kg/m² to 26 kg/m².

Exclusion criteria

  • Subjects with a history of malignant tumors (except for cancer with confirmed cure or remission for ≥5 years, radically resected basal or squamous cell skin cancer, carcinoma in situ of the cervix, and resected colonic polyps);
  • Subjects judged by the investigator to have any condition or disorder that may affect the absorption, metabolism, and/or excretion of the study drug.
  • Subjects with severe infection, severe trauma, or major surgery within 3 months prior to the screening or baseline period; or those with planned surgery during the trial period.
  • Subjects with a history of blood donation or significant blood loss (≥400 mL) within 8 weeks prior to the screening or baseline period, or those who have received a blood transfusion within 4 weeks prior to the screening or baseline period; or those who intend to donate blood during the trial period.
  • Subjects with a positive result for any of the following at screening: Hepatitis B virus surface antigen (HBsAg), human immunodeficiency virus (HIV) antibody, Treponema pallidum antibody, or hepatitis C virus antibody.
  • Subjects with a history of heavy smoking (averaging >5 cigarettes per day) within 4 weeks prior to screening or baseline, or those unable to discontinue the use of any tobacco products during the trial period.
  • Subjects with an average daily alcohol intake exceeding 15g (equivalent to 450 mL of beer, 150 mL of wine, or approximately 50 mL of low-alcohol liquor) within 4 weeks prior to the screening or baseline period; or those unable to abstain from alcohol during the trial; or those with a positive breath alcohol test at baseline.
  • Subjects with a history of drug abuse or drug dependency prior to screening or baseline; or those with a positive urine drug test at baseline.
  • Subjects who consumed excessive amounts of tea, coffee, or caffeine-containing beverages (averaging more than 8 cups per day, 250 mL per cup) within 48 hours prior to the first dose.
  • Subjects with specific dietary requirements who are unable to comply with the unified diet.
  • Subjects allergic to any component of the study drug; or those with a history of allergic diseases or a predisposition to allergies.
  • Subjects with dysphagia, difficulty with venous blood collection, or physical conditions that cannot tolerate intensive blood sampling.
  • Subjects judged by the investigator as unsuitable to participate in this trial for any other reason.

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
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan

Identifiers

NCT: NCT07493031 · HW252001-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗