ClinicalTrials.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

From the registry’s dates

  • Started Jul 2026; still recruiting 3 months later.
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

In context

Lead sponsor

Chengdu Zenitar Biomedical Technology Co., Ltd is the lead sponsor of 23 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 (BMI) between 19.0 and 28.0 kg/m\^2;
  3. Those who can understand the form, voluntarily participate in the experiment, and sign the informed consent form.

Exclusion criteria

Exclusion Criteria:

  1. Individuals with allergies or a history of 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 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。
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

05

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

06

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

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jul 2026 (actual). Primary completion is estimated for Jul 2027, 12 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 5, 2026
First posted
Aug 11, 2026
StartActual
Jul 23, 2026
Primary completionEst.
Jul 30, 2027
CompletionEst.
Dec 30, 2027
Last update
Aug 11, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07757152
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 ↗

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