A Study of HW243040 in Healthy Participants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HW243040, Placebo.
- Who it may be relevant to
- Registry conditions: Healthy. Basic parameters: 18 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 1, Randomized, Double-Blind, Single-Center, Dose-Escalation, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HW243040 in Healthy Participants
Overview
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
- Drug HW243040
HW243040 will be administered orally as a tablet. - Drug Placebo
Placebo will be administered orally as a tablet.
Primary outcome measures
- The incidence and severity of adverse events [Time frame: Up to day 11]
Secondary outcome measures (4)
- Maximum Concentration (Cmax) of HW243040 [Time frame: Up to day 11]
- Area Under the Concentration Versus Time Curve (AUC) of HW243040 [Time frame: Up to day 11]
- Time for Cmax (Tmax) of HW243040 [Time frame: Up to day 11]
- Half-life of HW243040 [Time frame: Up to day 11]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- The Third Xiangya Hospital of Central South University — Changsha
Identifiers
NCT: NCT07737496 · HW243040-101