Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07757152

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy adult participants for the Chinese trial, gender-neutral, aged 18 to 45;
  • 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;
  • Those who can understand the informed consent form, voluntarily participate in the experiment, and sign the informed consent form.

Exclusion criteria

  • 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;
  • .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;
  • 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;
  • 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。

Treatment and study plan

This group of participants take ZL-65 tablet

Drug

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

Drug

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

Primary outcomes

  1. Incidence of adverse events

    Time frame: day 1 to day 7

Secondary outcomes

  1. ZL65 Pharmacokinetics (PK):Cmax

    Time frame: 0-72hours

  2. ZL65 Pharmacokinetics (PK):Tmax

    Time frame: 0-72hours

  3. ZL65 Pharmacokinetics (PK):AUC0-t

    Time frame: 0-72hours

  4. ZL65 Pharmacokinetics (PK):AUC0-∞

    Time frame: 0-72hours

  5. ZL65 Pharmacokinetics (PK):t1/2

    Time frame: 0-72hours

Study contacts

Contact information is provided by the study sponsor or research team.

Wang Fangmei

CONTACT

[email protected]

+8613808086495

Sponsors and collaborators

Lead sponsor

Chengdu Zenitar Biomedical Technology Co., Ltd

Industry

Registry information

Official study title

Phase I Clinical Study of ZL-65 Tablet in Healthy Adult Participants in China: Randomized, Double-blind, Placebo-controlled, Single/Multiple Oral Dose Escalation for Safety Tolerability, Pharmacokinetics, Preliminary Pharmacodynamics, and Food Effect

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 11, 2026
Registry last updated
Aug 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.