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Phase I Clinical Study of ZL-65 Tablet in Healthy Adult Participants in China
Sponsor: Chengdu Zenitar Biomedical Technology Co., Ltd
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
Conditions
Interventions
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
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