NCT07593690Not yet recruitingPhase 1
A Phase I Study of HW241045 in Healthy Subjects
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.
Source: ClinicalTrials.gov · Last updated 18 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 102 (estimated)
- First submitted
- 12 May 2026
- Start date
- Jun 2026
- Primary completion date
- Jan 2027
- Lead sponsor
- Hubei Bio-Pharmaceutical Industrial Technological Institute Inc.
- Diseases
- Idiopathic pulmonary fibrosis
- NCT number
- NCT07593690
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 102
- From Jun 2026 to the primary completion date, Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Other
- Participants with any other factors deemed unsuitable for participation in the clinical study by the investigator.
Who the study is looking for
- 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).
Age in the registry: 18 years to 45 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital) Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.