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

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

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07757152

Enrollment

108

Registered

2026-08-11

Start date

2026-07-23

Completion date

2027-12-30

Last updated

2026-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Participants Study

Keywords

ZL65

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.

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

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

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。

Design outcomes

Primary

Measure	Time frame
Incidence of adverse events	day 1 to day 7

Secondary

Measure	Time frame
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

Countries

China

Contacts

CONTACTWang Fangmei

fangmei.wang@zenitar.cn+8613808086495

PRINCIPAL_INVESTIGATORYong Xiaolan, Doctor

Chengdu Xinhua Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 12, 2026