A Study to Investigate the Safety and Pharmacokinetic/Pharmacodynamic Characteristics of HSG4112
Condition: Obesity
Study type: Interventional
Phase: Phase 1

Summary: 
      1. Study Objective

           <Part 1> To evaluate the safety and pharmacokinetic/pharmacodynamic characteristics of
           HSG4112 after multiple oral administration in healthy female subjects.

           <Part 2> To evaluate the safety and pharmacokinetic/pharmacodynamic characteristics of
           HSG4112 after multiple oral administration in obese subjects.

        2. Background

           The previous phase 1 clinical trials investigating HSG4112 only included healthy male
           subjects, and food effect was observed in theses studies - the plasma exposure to
           HSG4112 following administration under fed conditions was approximately 2.5 times higher
           compared to the exposure following administration under fasted conditions. Therefore,
           this study is designed to evaluate the safety of HSG4112 in healthy female subjects and
           obese subjects following the administration of HSG4112 under fed conditions.

        3. Study Design and Plan

      <Part 1> This study is a dose block-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. In each dose group,
      8 subjects will be randomized to receive HSG4112 and 2 subjects will be randomized to receive
      placebo. 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
      consecutive days. After the Post-Study Visit of the last volunteer in the 480 mg dose group,
      the Investigator will review all the available safety data in a blinded manner to ensure if
      it is safe to proceed with the 720 mg dose group. 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 pharcokinetic/pharmacodynamic characteristics of HSG4112.

      <Part 2> This study is a dose block-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. In each dose group,
      8 subjects will be randomized to receive HSG4112 and 2 subjects will be randomized to receive
      placebo. 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
      consecutive days. 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
      pharcokinetic/pharmacodynamic characteristics of HSG4112.
    


Intervention name(s): HSG4112; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Once-daily, 14-day multiple oral administration; Once-daily, 14-day multiple oral administration
Other intervention name(s): 2-(8,8 dimethyl 2,3,4,8,9,10 hexahydropyrano[2,3 f]chromen 3 yl) 5 ethoxyphenol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment