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

NCT04732988 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2021-11-01

No results posted yet for this study

Summary

1. Study Objective: The objective of this phase 1 clinical trial is to evaluate the safety, tolerability, pharmacokinetic/pharmacodynamic characteristics and food effect of HSG4112 after oral administration in healthy male subjects.
2. Study Design and Plan: This study is a dose-block randomized, double-blind, placebo-controlled, single and multiple dosing, dose-escalation phase 1 clinical trial. 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 six groups for the single ascending dose (SAD) study or one of the three groups for the multiple ascending dose (MAD) study. Each dose group will consist of ten subjects, and among the ten subjects, eight subjects will be randomized to receive HSG4112 and two 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. The dosing duration for the MAD study is 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 electrocardiogram, laboratory test, semen analysis (MAD study only), physical examination, and adverse event monitoring will be performed. Blood samples will be collected to evaluate the pharmacokinetic/pharmacodynamic characteristics of HSG4112.

Conditions

Interventions

DRUG

HSG4112

Once-daily oral administration

DRUG

Placebo

Once-daily oral administration

Sponsors & Collaborators

  • Seoul National University Hospital

    collaborator OTHER

  • Kyungpook National University Hospital

    collaborator OTHER

  • Glaceum

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-08-23
Primary Completion
2021-05-24
Completion
2021-05-24

Countries

  • South Korea

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04732988 on ClinicalTrials.gov