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Clinical Trials in China / NCT07757152
Recruiting Phase 1

Phase I Clinical Study of ZL-65 Tablet in Healthy Adult Participants in China

NCT07757152 · tracked via the Priya Life Science China tracker
Sponsor
Chengdu Zenitar Biomedical Technology Co., Ltd
Phase
Phase 1
Started
2026-07-23
Last updated
2026-08-11

Condition(s) studied

Healthy Participants Study

Investigational drug(s) / intervention(s)

This group of participants take ZL-65 tabletThis group of participants take ZL-65 placebo tablet

This group of participants take ZL-65 tablet: ZL65 Tablet 5mg ZL65 Tablet 10mg ZL65 Tablet 25mg ZL65 Tablet 50mg ZL65 Tablet 75mg ZL65 Tablet 100mg ZL65 Tablet 125mg

This group of participants take ZL-65 placebo tablet: ZL65 Placebo Tablet 5mg ZL65 Placebo Tablet 10mg ZL65 Placebo Tablet 25mg ZL65 PlaceboTablet 50mg ZL65 Placebo Tablet 75mg ZL65 Placebo Tablet 100mg ZL65 Placebo Tablet 125mg

Study 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

Sex
ALL
Min age
18 Years
Max age
45 Years
Healthy volunteers
Accepted
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。

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Chengdu Xinhua Hospital Chengdu Sichuan Recruiting

More Chengdu Zenitar Biomedical Technology Co., Ltd trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07757152 on ClinicalTrials.gov ↗ ← All trials in China