Healthy
Conditions
Brief summary
This is a randomised, double-blind, placebo-controlled clinical trial intended to evaluate the safety, tolerability and pharmacokinetic profiles of HW243040 following single and multiple administrations in healthy study participants.
Interventions
DRUGHW243040
HW243040 will be administered orally as a tablet.
DRUGPlacebo
Placebo will be administered orally as a tablet.
Sponsors
Hubei Bio-Pharmaceutical Industrial Technological Institute Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Informed consent must be obtained/signed prior to trial participation. * Aged between 18 and 55 years old, both healthy males and females are eligible. * Female participates must have a body weight of ≥ 45 kg and male participates ≥ 50 kg, with a body mass index (BMI) ranging from 19 to 26 kg/m\^2.
Exclusion criteria
* History or presence of any clinically severe disorders of urinary, cardiovascular, endocrine, nervous, gastrointestinal, respiratory, hematologic, immune systems, psychiatric illnesses or metabolic abnormalities; or other conditions judged by the Investigator to confound trial outcomes, e.g., intestinal diseases (irritable bowel syndrome), urinary tract infections. * History of malignant tumors (except for cancer with confirmed cure or remission for ≥5 years, radically resected basal or squamous cell skin cancer, carcinoma in situ of the cervix, and resected colonic polyps). * Any conditions or diseases that, in the Investigator's judgment, may affect the absorption, metabolism and/or excretion of the investigational product. * History of drug abuse or dependence. * Hypersensitivity to any ingredient of the study drug，or history of allergic disorders or allergic diathesis. * Any other condition that, in the opinion of the investigator, renders the participant unsuitable to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence and severity of adverse events | Up to day 11 |
Secondary
| Measure | Time frame |
|---|---|
| Maximum Concentration (Cmax) of HW243040 | Up to day 11 |
| Area Under the Concentration Versus Time Curve (AUC) of HW243040 | Up to day 11 |
| Time for Cmax (Tmax) of HW243040 | Up to day 11 |
| Half-life of HW243040 | Up to day 11 |
Countries
China
Contacts
CONTACTLifei Liu
Outcome results
None listed