Single-dose safety and pharmacokinetics of HW241045 in healthy adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, placebo-controlled Phase Ia single-ascending-dose trial in healthy volunteers to characterize the safety, tolerability, and pharmacokinetics of HW241045. Participants will be assigned to ascending dose cohorts receiving either HW241045 or placebo with close clinical monitoring for adverse events, vital signs, ECGs, and laboratory parameters, and serial blood sampling for PK analysis. Eligible participants are healthy men and women aged 18–55 with specified weight and BMI ranges, and individuals with significant medical conditions or recent major surgery are excluded. The trial is sponsored by Hubei Bio-Pharmaceutical Industrial Technological Institute and conducted at Peking Union Medical College Hospital in Beijing.

Why it matters

Who can join: the full rules

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.

Where it's running

• Peking Union Medical College Hospital
  Beijing, China Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Photon-counting CT vs standard HRCT to help diagnose IPF and other ILDs

  This study tests whether photon-counting CT can improve identifying IPF and other ILDs compared with standard HRCT for patients discussed in multidisciplinary teams.

  Recruiting Istituto Clinico Humanitas · Rozzano, Italy · NCT07790614

• Evaluating SB17170 in patients with idiopathic pulmonary fibrosis

  This study is testing a new drug called SB17170 to see if it can help adults with moderate to severe idiopathic pulmonary fibrosis breathe better over 12 weeks.

  Recruiting at 2 sites Phase 2 SPARK Biopharma · Goyang and 4 other locations · NCT06747923

• Identifying biomarkers for progressive pulmonary fibrosis in lung disease patients

  This study is trying to find early signs that can help predict if adults with certain lung diseases will develop progressive pulmonary fibrosis over the next five years.

  Recruiting Amsterdam UMC, location VUmc · Amsterdam, North Holland · NCT06644144

• Exploring the links between sleep hygiene, muscle loss, and brain function in lung disease

  This study looks at how good or bad sleep affects muscle loss and brain function in people with lung diseases like COPD and IPF.

  Recruiting National Hospital Organization Minami Kyoto Hospital · Jōyō, Kyoto · NCT05193136

• Telerehabilitation for patients with idiopathic pulmonary fibrosis

  This study is testing two different online exercise programs to see which one helps people with idiopathic pulmonary fibrosis feel better after 8 weeks of workouts.

  Recruiting Istanbul Medipol University Hospital · Istanbul, Zeytinburnu · NCT05190211

• Investigating the link between laryngopharyngeal reflux and idiopathic pulmonary fibrosis

  This study is testing if a new way to measure throat reflux can help doctors understand how it affects people with idiopathic pulmonary fibrosis.

  Recruiting National Jewish Health · Denver, Colorado · NCT03418350

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.