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NCT07737496
A Study of HW243040 in Healthy Participants
Conditions: Healthy
Sex: All
Ages: 18 Years – 55 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 98
Sponsor: Hubei Bio-Pharmaceutical Industrial Technological Institute Inc.
Location: The Third Xiangya Hospital of Central South University Changsha Hunan
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.
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.
Source: ClinicalTrials.gov (NCT07737496). StuddyBuddy aggregates publicly available trial information.