Actively Recruiting
A Phase Ia Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of HW241045 Tablets Following a Single Dose in Healthy Subjects
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 drug’s 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
Eligibility Criteria
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
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 48 hours
Participants receive a single oral dose of HW241045 or placebo and are monitored for safety, tolerability, and pharmacokinetics.
1 dosing visit and follow-up assessments within 48 hours
Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital
Beijing, China, 100730
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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