RecruitingPhase 1NCT05642377

A Study to Investigate the Safety, Tolerability, Pharmacokinetic/Pharmacodynamic Characteristics and Food Effect of HGR4113 in Healthy Subjects

A Randomized, Double-Blind, Placebo Controlled, Single and Multiple Dosing, Dose-Escalation Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic/Pharmacodynamic Characteristics and Food Effect After Oral Administration of HGR4113 in Healthy Subjects


Sponsor

Glaceum

Enrollment

40 participants

Start Date

Nov 22, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

1. Study Objective: The objective of this study is to evaluate the safety, tolerability, pharmacokinetic/pharmacodynamic characteristics, and food effect of HGR4113 after single and multiple oral administration in healthy subjects. 2. Study Design and Plan: This study is a randomized, double-blind, placebo controlled, single and multiple dosing, dose-escalation phase 1 clinical trial. Volunteers who have been deemed eligible based on the inclusion/exclusion criteria will be given a random number. Each subject will be assigned to one of the dose groups in a 6:2 ratio to HGR4113 (active) or placebo. Subjects will be studied in a double-blind manner and will receive the investigational product per protocol. Dose will be escalated once safety data is collected up to the last pharmacokinetic blood collection timepoint and safety and tolerability has been deemed acceptable following the review of the Safety Review Committee. Assessments including vital signs, 12-lead ECG, clinical laboratory, reproductive hormones, physical examination, and monitoring of adverse events concomitant medications will be conducted to evaluate safety and tolerability. Blood will be collected to evaluate the pharmacokinetic/pharmacodynamic characteristics.


Eligibility

Min Age: 19 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called HGR4113 in healthy volunteers to understand how safe it is, how the body absorbs and processes it, and whether eating affects the way the drug works. **You may be eligible if...** - You are a healthy adult between 19 and 50 years old - Your body mass index (BMI) is between 18.0 and 24.9 - You have no significant health conditions and your routine medical tests are normal - You are willing and able to follow all study procedures **You may NOT be eligible if...** - You have a history of significant liver, kidney, heart, neurological, immune, blood, or cancer conditions - You are currently taking any prescription medications or supplements that could interfere with the study drug - You are pregnant, breastfeeding, or not willing to use contraception - You have used tobacco products or recreational drugs recently 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

DRUGHGR4113

Once-daily oral administration

DRUGPlacebo

Once-daily oral administration

DRUGHGR4113

Twice-daily oral administration

DRUGPlacebo

Twice-daily oral administration


Locations(1)

Seoul National University Hospital

Seoul, South Korea

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NCT05642377


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