A Study to Investigate the Safety, Tolerability, Pharmacokinetic/Pharmacodynamic Characteristics and Food Effect of HSG4112 in High Doses

Obesity Clinical Trial

Official title: A Randomized, Open-label or 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 HSG4112 in Healthy Subjects

Status Completed

Clinical Trial Summary

1. Study Objective

i) To evaluate the safety, tolerability and pharmacokinetic/pharmacodynamic characteristics of HSG4112 after single and multiple oral administration of high doses in healthy subjects.

ii) To evaluate the food effect on the pharmacokinetic characteristics of HSG4112 after a single oral administration of 1200 mg (6 tablets of HSG4112 200 mg) in healthy subjects.

2. Background

The previous phase 1 clinical trials investigating HSG4112 included dosage only up to 720 mg of HSG4112 in both healthy and obese subjects. Since obese patients have various comorbidities, unexpected drug interactions may occur due to concomitant drugs. Securing a 2- to 5-fold safety margin is needed to tolerate this issue. Therefore, this study is designed to evaluate the safety, tolerability, pharmacokinetic/pharmacodynamic characteristics and food effects of high-dose HSG4112 in healthy subjects.

3. Study Design and Plan

<Part 1> This study is a randomized, open-label, single dosing, phase 1 clinical study. A unique randomization number will be assigned to each subject deemed eligible to participate in the study based on the inclusion/exclusion criteria. Each subject will be randomized to one of the two dose groups. 8 subjects will receive 800 mg of HSG4112 with a high-fat meal, and 12 subjects will be randomized to 2 different sequential groups. Each subject will receive a single dose of HSG4112 1200 mg via oral administration with a high-fat meal and in fasted condition, with a washout period of 21 days in between each dosing. When escalating the dose, the Investigator will review all of the available safety data from the preceding dose in a blinded manner to ensure if it is safe to escalate the dose. In order to evaluate safety and tolerability, assessments, such as vital signs, 12-lead ECG, laboratory test, pregnancy test, physical examination, and adverse event monitoring will be performed. Blood samples will be collected to evaluate the pharmacokinetic/pharmacodynamic characteristics of HSG4112.

<Part 2> This study is a randomized, double-blind, placebo-controlled, multiple dosing, phase 1 clinical study. A unique randomization number will be assigned to each subject deemed eligible to participate in the study based on the inclusion/exclusion criteria. Each subject will be randomized to one of the two dose groups (800 mg or 1200 mg of HSG4112). In each dose group, 6 subjects will be randomized to receive 800 mg of HSG4112, and 2 subjects will be randomized to receive placebo, both with a high-fat meal. The subjects will be studied in a double-blind manner and will receive the investigational product (i.e., HSG4112 or placebo) via once-daily oral administration for 14 days. When escalating the dose, the Investigator will review all of the available safety data from the preceding dose in a blinded manner to ensure if it is safe to escalate the dose. In order to evaluate safety and tolerability, assessments, such as vital signs, 12-lead ECG, laboratory test, pregnancy test, physical examination, and adverse event monitoring will be performed. Blood samples will be collected to evaluate the pharmacokinetic/pharmacodynamic characteristics of HSG4112.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Obesity

• NCT number: NCT05310032
• Study type: Interventional
• Source: Glaceum
• Status: Completed
• Phase: Phase 1
• Start date: April 21, 2022
• Completion date: March 31, 2023