NCT07757152

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P75+ for phase_1

Timeline
17mo left

Started Jul 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress4%
Jul 2026Dec 2027

Study Start

First participant enrolled

July 23, 2026

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

August 5, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 11, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2027

Last Updated

August 11, 2026

Status Verified

July 1, 2026

Enrollment Period

1 year

First QC Date

August 5, 2026

Last Update Submit

August 5, 2026

Conditions

Healthy Participants Study

Keywords

ZL65

Outcome Measures

Primary Outcomes (1)

  • Incidence of adverse events

    day 1 to day 7

Secondary Outcomes (5)

  • ZL65 Pharmacokinetics (PK)：Cmax

    0-72hours

  • ZL65 Pharmacokinetics (PK)：Tmax

    0-72hours

  • ZL65 Pharmacokinetics (PK)：AUC0-t

    0-72hours

  • ZL65 Pharmacokinetics (PK)：AUC0-∞

    0-72hours

  • ZL65 Pharmacokinetics (PK)：t1/2

    0-72hours

Study Arms (2)

ZL65 Tables

EXPERIMENTAL

ZL65

Drug: This group of participants take ZL-65 tablet

ZL65-Placebo Tables

PLACEBO COMPARATOR
Drug: This group of participants take ZL-65 placebo tablet

Interventions

This group of participants take ZL-65 tabletDRUG

ZL65 Tablet 5mg ZL65 Tablet 10mg ZL65 Tablet 25mg ZL65 Tablet 50mg ZL65 Tablet 75mg ZL65 Tablet 100mg ZL65 Tablet 125mg

ZL65 Tables
This group of participants take ZL-65 placebo tabletDRUG

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

ZL65-Placebo Tables

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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。

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chengdu Xinhua Hospital

Chengdu, Sichuan, China

RECRUITING

Study Officials

  • Yong Xiaolan, Doctor

    Chengdu Xinhua Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wang Fangmei

CONTACT

+8613808086495fangmei.wang@zenitar.cn

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2026

First Posted

August 11, 2026

Study Start

July 23, 2026

Primary Completion (Estimated)

July 30, 2027

Study Completion (Estimated)

December 30, 2027

Last Updated

August 11, 2026

Record last verified: 2026-07

Locations

CN(1)