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RECRUITING
NCT07757152
PHASE1

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

Sponsor: Chengdu Zenitar Biomedical Technology Co., Ltd

View on ClinicalTrials.gov

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.

Official 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

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

108

Start Date

2026-07-23

Completion Date

2027-12-30

Last Updated

2026-08-11

Healthy Volunteers

Yes

Interventions

DRUG

This 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

DRUG

This 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

Locations (1)

Chengdu Xinhua Hospital

Chengdu, Sichuan, China