NCT07757152 Phase I Clinical Study of ZL-65 Tablet in Healthy Adult Participants in China
| NCT ID | NCT07757152 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Chengdu Zenitar Biomedical Technology Co., Ltd |
| Condition | Healthy Participants Study |
| Study Type | INTERVENTIONAL |
| Enrollment | 108 participants |
| Start Date | 2026-07-23 |
| Primary Completion | 2027-07-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 108 participants in total. It began in 2026-07-23 with a primary completion date of 2027-07-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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。
Contact & Investigator
Yong Xiaolan, Doctor
PRINCIPAL INVESTIGATOR
Chengdu Xinhua Hospital
Frequently Asked Questions
Who can join the NCT07757152 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 45 Years, studying Healthy Participants Study. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07757152 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07757152 currently recruiting?
Yes, NCT07757152 is actively recruiting participants. Contact the research team at fangmei.wang@zenitar.cn for enrollment information.
Where is the NCT07757152 trial being conducted?
This trial is being conducted at Chengdu, China.
Who is sponsoring the NCT07757152 clinical trial?
NCT07757152 is sponsored by Chengdu Zenitar Biomedical Technology Co., Ltd. The principal investigator is Yong Xiaolan, Doctor at Chengdu Xinhua Hospital. The trial plans to enroll 108 participants.