Single-dose safety and pharmacokinetics of HW241045 in healthy adults

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

This trial will test single ascending doses of HW241045 in healthy adults (18–55) to see if the drug is safe, well tolerated, and how it is processed by the body.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Hubei Bio-Pharmaceutical Industrial Technological Institute Inc. (Industry-sponsored)
• Locations: 1 site (Beijing)
• Trial ID: NCT07448194 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are healthy men and women aged 18–55 who meet the weight (female ≥45 kg, male ≥50 kg) and BMI (19–26 kg/m²) criteria and have no significant medical history.

Not a fit: People with active or recent major medical conditions, recent severe trauma or surgery, abnormal screening labs, or those outside the age, weight, or BMI limits are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the trial could identify a safe dose range and early pharmacokinetic profile to support further development of HW241045 for conditions such as IPF.

How similar studies have performed: Single-ascending-dose, randomized placebo-controlled Phase I trials are the standard first-in-human approach and have supported many drugs' development, while HW241045 appears to be at an early, first-in-human stage.

Eligibility 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.

Where this trial is running

Beijing

• Peking Union Medical College Hospital — Beijing, China (Recruiting)

Conditions Healthy Volunteers; IPF; HW241045; healthy volunteers; Safety; Pharmacokinetics