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Actively Recruiting

Phase 1
Age: 18Years - 55Years
All Genders
Healthy Volunteers
ID07448194

Phase Ia Study Evaluating Safety, Tolerability, and Pharmacokinetics of HW241045 Tablets as a Single Dose in Healthy Adults

Led by Hubei Bio-Pharmaceutical Industrial Technological Institute Inc. · Updated on 2026-03-04

56

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying HW241045 in a Phase Ia clinical trial to evaluate its safety, tolerability, and how it is processed in the body after a single dose. This randomized, double-blind, placebo-controlled study involves healthy adult volunteers aged 18 to 55 years to better understand the effects of this drug compared to a placebo. Participants will receive a single oral dose of either HW241045 or a placebo. The study is designed with two groups one receiving the experimental drug and the other receiving placebo, both under blinded conditions to ensure unbiased results. The trial is conducted at a single center and uses a quadruple masking approach. During the study, participants will be closely monitored for any treatment-emergent adverse events within 48 hours after dosing. Assessments include safety checks, tolerability evaluations, and pharmacokinetic measurements. Participants health will be carefully observed during this period to understand the drugs effects and side effects. The total duration of participation is determined by these assessments and monitoring schedules.

CONDITIONS

Brief Title

A Phase Ia Clinical Trial of HW241045

Who Can Participate

Age: 18Years - 55Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Subjects fully informed about the trial and voluntarily sign consent
  • Healthy male and female subjects aged 18 to 55 years
  • Female subjects must weigh at least 45 kg and male subjects at least 50 kg
  • Body mass index (BMI) between 19 and 26 kg/m²
Not Eligible

You will not qualify if you...

  • History or current severe diseases affecting circulatory, endocrine, nervous, digestive, respiratory, hematological, immune, mental, or metabolic systems
  • Severe trauma or major surgery within 3 months before screening or planned surgery during the trial or within two weeks after
  • History of gastrointestinal, liver, or kidney diseases affecting drug absorption or metabolism
  • Clinically significant abnormal screening test results
  • History of drug or food allergy, allergic disorders, or sensitivity to any component of the study drug
  • Difficult venous blood collection or inability to tolerate intensive blood sampling
  • Judged unsuitable for the study by the investigator due to other reasons

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