RecruitingPhase 1NCT06627556

A Study of Single and Multiple Ascending Doses of H021 in Healthy Participants

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of H021 in Healthy Participants


Sponsor

Jiangsu Carephar Pharmaceutical Co., Ltd.

Enrollment

64 participants

Start Date

Sep 17, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The primary purpose of this study is to evaluate the safety and tolerability of H021 tablets following oral administration of single and multiple ascending doses in healthy participants.


Eligibility

Min Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This is a Phase 1 safety study of a new experimental drug called H021 in healthy volunteers. The study gives participants increasing doses — first in single doses, then in multiple doses over time — to understand how the body absorbs, processes, and tolerates the drug. **You may be eligible if...** - You are between 18 and 55 years old - You are a non-smoker (no tobacco or nicotine for at least 3 months) - You have a BMI between 18.5 and 32.0 - You are in good general health with no significant chronic illnesses - Women must be post-menopausal or using reliable contraception **You may NOT be eligible if...** - You have a history of significant neurological, heart, liver, kidney, or psychiatric disease - You have had a significant illness or surgery in the past 4 weeks - You are pregnant or breastfeeding - You are taking medications that could interfere with the study drug Talk to your doctor to see if this trial is right for you.

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

DRUGH021

H021 oral tablet.

DRUGH021 Placebo

H021 placebo oral tablet.


Locations(1)

Nucleus Network Ply Ltd.

Melbourne, Victoria, Australia

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NCT06627556


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