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A Study of HY209 in Healthy Male Volunteers for Sepsis

Sponsor
Shaperon (Industry)
Overall Status
Completed
CT.gov ID
NCT04255979
Collaborator
(none)
40
Enrollment
1
Location
6
Arms
6.2
Actual Duration (Months)
6.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized, double-blind, placebo-controlled single dosing, dose escalationRandomized, double-blind, placebo-controlled single dosing, dose escalation
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Dec 5, 2019
Actual Primary Completion Date :
Jun 12, 2020
Actual Study Completion Date :
Jun 12, 2020

Arms and Interventions

Arm Intervention/Treatment
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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of treatment emergent adverse events (TEAEs) [Up to Day 6]

      Number of subjects with abnormal laboratory values and/or adverse events that are related to treatment

    Secondary Outcome Measures

    1. Maximum concentration (Cmax) of HY209 [Up to Day 2]

      Maximum concentration of HY209 in plasma

    2. Ratio of area under curve infinity (AUCinf) of HY209 [Up to Day 2]

      Area under the plasma HY209 concentration-time curve over the time interval from 0 extrapolated to infinity

    3. Ratio of area under curve last (AUClast) of HY209 [Up to Day 2]

      Area under the plasma HY209 concentration-time curve over the time interval from 0 to the last quantifiable plasma concentration

    4. Time of maximum concentration (Tmax) of HY209 [Up to Day 2]

      Time of maximum concentration of HY209 in plasma

    5. Terminal halif-life (t1/2) of HY209 [Up to Day 2]

      Terminal half-life of HY209 in plasma

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 45 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seoul National University Hospital Seoul Jongno-gu Korea, Republic of 03080

    Sponsors and Collaborators

    • Shaperon

    Investigators

    • Principal Investigator: In-jin Jang, Seoul National University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Shaperon
    ClinicalTrials.gov Identifier:
    NCT04255979
    Other Study ID Numbers:
    • HY209-IV
    First Posted:
    Feb 5, 2020
    Last Update Posted:
    Nov 30, 2020
    Last Verified:
    Nov 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Sepsis

    Study Results

    No Results Posted as of Nov 30, 2020