HW243040 first-in-human safety in healthy adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, placebo-controlled Phase 1 study in healthy adults to assess the safety, tolerability, and pharmacokinetics of single and multiple doses of HW243040. Participants will be assigned to receive either HW243040 or placebo and will undergo safety assessments and PK sampling over a defined period. The trial aims to determine initial dosing feasibility and identify any adverse events in a controlled setting. Enrollment is limited to adults aged 18 to 55 with specific weight and BMI criteria, and strict exclusion criteria are applied to minimize confounding factors. The study is sponsored by Hubei Bio-Pharmaceutical Industrial Technological Institute Inc. and conducted at The Third Xiangya Hospital of Central South University in Changsha, China.

Why it matters

Who can join: the full rules

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.

Where it's running

• The Third Xiangya Hospital of Central South University
  Changsha, Hunan, China Recruiting

Study contacts

• Study coordinator: Lifei Liu
• Email: liulifei@renfu.com.cn
• Phone: 86-027-87173753

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.