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RecruitingPhase 1NCT07757152

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

Sponsor

Chengdu Zenitar Biomedical Technology Co., Ltd

Enrollment

108 participants

Start Date

Jul 23, 2026

Study Type

INTERVENTIONAL

Conditions

Healthy Participants 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.

Eligibility

Min Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called This group of participants take ZL-65 placebo tablet and a drug called This group of participants take ZL-65 tablet for people with healthy participants study. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 45 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

Locations(1)

Chengdu Xinhua Hospital

Chengdu, Sichuan, China

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NCT07757152

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