A Study of HY209 in Healthy Male Volunteers for Sepsis

November 27, 2020 updated by: Shaperon

A Randomized, Double-blind, Placebo-controlled Single Dosing, Dose Escalation Phase I Clinical Trial to Investigate the Safety/Tolerability and Pharmacokinetics of HY209 After Intravenous Administration in Healthy Male Volunteers

A randomized, double-blind, placebo-controlled single dosing, dose escalation phase I clinical trial to investigate the safety/tolerability and pharmacokinetics of HY209 after intravenous administration in healthy male volunteers

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

HY209, which is being developed for the treatment of sepsis, inhibits inflammation by promoting the differentiation and division of Myeloid-derived suppressor cells (MDSCs).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Jongno-gu
      • Seoul, Jongno-gu, Korea, Republic of, 03080
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Healthy male aged from 19 to 45 at screening test
  • BMI 18 kg/m2 ~ 27 kg/m2 at screening test
  • Subjects found to be clinically healthy by medical history, physical examination, vital signs, electrocardiogram (ECG), and appropriate laboratory tests
  • Those who must be capable of giving informed consent and willing to comply with all clinic visits and study-related procedures for the duration of study until study completion

Exclusion Criteria:

  • Those who have a history of hypersensitivity or clinically significant hypersensitivity reactions to drugs (containing Taurodeoxycholate component, aspirin, antibiotics, etc.)
  • Those who showed clinical symptoms suspected of acute infectious disease within 2 weeks before the first does, or whose body temperature (ear canal) measured at screening showed 38 ℃ or higher
  • Those who have a clinically significant disease of liver, kidney, digestive, respiratory, endocrine, neurologic, blood/tumor, cardiovascular system history of those diseases
  • Those who have a history of gastrointestinal diseases or surgery that may affect the absorption of the investigational drug
  • Those who have a history of substance abuse or have tested positive for drugs of concern for misuse by urine drug screening
  • Patients with the following blood pressure measured at the seat after resting for more than 5 minutes at the screening visit [Systolic blood pressure (SBP): < 90 mmHg or > 150 mmHg, Diastolic blood pressure (DBP): < 50 mmHg or > 90 mmHg]
  • Those who participated in other clinical trials or bioequivalence within 6 months prior to the first dosing and received the drug
  • Those who have donated whole blood within 2 months before the first dose or ingredient donation within 1 month or received blood transfusion within 1 month
  • Those who have taken metabolic enzyme-induced and inhibitory drugs within 1 month before screening
  • Those who consumed grapefruit / caffeine-containing foods within 3 days of the first dose and who cannot refrain from eating grapefruit-containing foods from 3 days before admission to discharge date
  • Those who have taken specialty or herbal medicines within 2 weeks of the first dose or who have taken over-the-counter (OTC) within 1 week
  • Caffeine overdose, alcohol overdose or oversmoker
  • Those who have unusual eating habits or who are unable to eat the meals provided in this clinical trial
  • Other investigator judged to be unsuitable as clinical subject

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cohort 1
Single dose of HY209 0.1 mg/kg or placebo.
Drug: HY209
6 Subjects will be assigned to drug (HY209) and 2 subjects will be assigned to placebo.
Other Names:
  • HY209-IV
Experimental: Cohort 2
Single dose of HY209 0.2 mg/kg or placebo.
Drug: HY209
6 Subjects will be assigned to drug (HY209) and 2 subjects will be assigned to placebo.
Other Names:
  • HY209-IV
Experimental: Cohort 3
Single dose of HY209 0.4 mg/kg or placebo.
Drug: HY209
6 Subjects will be assigned to drug (HY209) and 2 subjects will be assigned to placebo.
Other Names:
  • HY209-IV
Experimental: Cohort 4
Single dose of HY209 0.8 mg/kg or placebo.
Drug: HY209
6 Subjects will be assigned to drug (HY209) and 2 subjects will be assigned to placebo.
Other Names:
  • HY209-IV
Experimental: Cohort 5
Single dose of HY209 1.6 mg/kg or placebo.
Drug: HY209
6 Subjects will be assigned to drug (HY209) and 2 subjects will be assigned to placebo.
Other Names:
  • HY209-IV
Experimental: Cohort 6
Single dose of HY209 3.2 mg/kg or placebo.
Drug: HY209
6 Subjects will be assigned to drug (HY209) and 2 subjects will be assigned to placebo.
Other Names:
  • HY209-IV

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of treatment emergent adverse events (TEAEs)
Time Frame: Up to Day 6
Number of subjects with abnormal laboratory values and/or adverse events that are related to treatment
Up to Day 6

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Maximum concentration (Cmax) of HY209
Time Frame: Up to Day 2
Maximum concentration of HY209 in plasma
Up to Day 2
Ratio of area under curve infinity (AUCinf) of HY209
Time Frame: Up to Day 2
Area under the plasma HY209 concentration-time curve over the time interval from 0 extrapolated to infinity
Up to Day 2
Ratio of area under curve last (AUClast) of HY209
Time Frame: Up to Day 2
Area under the plasma HY209 concentration-time curve over the time interval from 0 to the last quantifiable plasma concentration
Up to Day 2
Time of maximum concentration (Tmax) of HY209
Time Frame: Up to Day 2
Time of maximum concentration of HY209 in plasma
Up to Day 2
Terminal halif-life (t1/2) of HY209
Time Frame: Up to Day 2
Terminal half-life of HY209 in plasma
Up to Day 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shaperon

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: In-Jin Jang, Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 5, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 12, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 12, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 3, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 5, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 30, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HY209-IV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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