ZL-65 tablet in healthy adults: safety, tolerability, and pharmacokinetics in China

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 Phase 1 study evaluates a single oral dose of ZL-65 tablets in healthy adult participants to assess safety, tolerability, and basic pharmacokinetic and pharmacodynamic characteristics. The trial uses a dose-escalation design to identify initial tolerability limits and to observe how food intake may influence drug exposure. An open question in this study is how ZL-65 behaves in the body when taken with and without food, and how it may affect biological markers in healthy volunteers. The study compares ZL-65 to a placebo to help distinguish drug effects from background variation. Conducted at Chengdu Xinhua Hospital, the trial is sponsored by Chengdu Zenitar Biomedical Technology Co., with healthy volunteers meeting predefined eligibility criteria.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Healthy adult participants for the Chinese trial, gender-neutral, aged 18 to 45;
2. Male trial participants weighing \>= 50.0 kg, female trial participants weighing \>=45.0 kg, with a body mass index (BMI) between 19.0 and 28.0 kg/m\^2;
3. Those who can understand the informed consent form, voluntarily participate in the experiment, and sign the informed consent form.

Exclusion Criteria:

1. Individuals with allergies or a history of clinically significant food, drug allergies, or other allergic diseases as determined by researchers; Or those who are known to be allergic to NLRP3 inhibitors or to the excipients contained in the test drug;
2. .Individuals with any serious illness or medical history of cardiovascular system, digestive system, urinary system, respiratory system, nervous system, immune system, endocrine system, malignant tumors, mental illness, etc;
3. Pregnant or lactating women or women of childbearing age who have had unprotected sexual intercourse with their partners within 14 days prior to screening; Or those with positive results in blood pregnancy test;
4. Within 48 hours prior to administration, consuming any food or beverage containing caffeine, or fruits or vegetables containing grapefruit juice, soybeans, flavonoids that may affect metabolic enzymes, or consuming foods or beverages containing alcohol。

Where it's running

• Chengdu Xinhua Hospital
  Chengdu, Sichuan, China Recruiting

Study contacts

• Principal investigator: Yong Xiaolan, Doctor — Chengdu Xinhua Hospital
• Study coordinator: Wang Fangmei
• Email: fangmei.wang@zenitar.cn
• Phone: +8613808086495

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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.