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NCT07757152
Phase I Clinical Study of ZL-65 Tablet in Healthy Adult Participants in China
Conditions: Healthy Participants Study
Sex: All
Ages: 18 Years – 45 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 108
Sponsor: Chengdu Zenitar Biomedical Technology Co., Ltd
Location: Chengdu Xinhua Hospital Chengdu Sichuan
Summary
To evaluate the tolerability and safety of a single oral dose of ZL-65 tablets in healthy adult trial participants through dose escalation; and to preliminarily assess the pharmacokinetic and pharmacodynamic characteristics of a single oral dose of ZL-65 tablets.Exploring the impact of food intake on the PK of orally administered ZL-65 tablets in healthy adult trial participants.
Eligibility Criteria
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。
Source: ClinicalTrials.gov (NCT07757152). StuddyBuddy aggregates publicly available trial information.