CClinicalTrials.gg
RecruitingNCT07757152Updated Aug 11, 2026

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

A Phase 1 interventional study of This group of participants take ZL-65 tablet and This group of participants take ZL-65 placebo tablet in Healthy Participants Study, sponsored by Chengdu Zenitar Biomedical Technology Co., Ltd. Recruiting at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-11.

Sponsored by Chengdu Zenitar Biomedical Technology Co., Ltd · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
108
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

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.

02

Conditions studied

  • Healthy Participants Study

Keywords

  • ZL65
03

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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。
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
108 participants (estimated)

Study arms

  • Experimental
    ZL65 Tables

    ZL65

    Drug: This group of participants take ZL-65 tablet

  • Placebo comparator
    ZL65-Placebo Tables

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

Interventions

  • DrugThis 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

  • DrugThis 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

05

What researchers measure

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

06

Study locations

1 of 1 sites recruiting
  • Chengdu Xinhua Hospital
    Chengdu, Sichuan, China
    Recruiting
07

Registry details

Key details

Study ID
NCT07757152
Lead sponsor
Chengdu Zenitar Biomedical Technology Co., Ltd
Responsible party
Sponsor
First posted
Aug 11, 2026
Start date
Jul 23, 2026
Primary completion
Jul 30, 2027 (estimated)
Completion
Dec 30, 2027 (estimated)
Last update
Aug 11, 2026

Study contacts

Wang Fangmei
Contact
fangmei.wang@zenitar.cn
+8613808086495
Yong Xiaolan, Doctor
principal investigator · Chengdu Xinhua Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion