A Study of HY209 in Healthy Male Volunteers for Sepsis

NCT04255979 | Completed Phase 1

• 1 other identifier: HY209-IV
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Sepsis

Outcome Measures

Primary Outcomes (1)

• Incidence of treatment emergent adverse events (TEAEs)

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

  Up to Day 6

Secondary Outcomes (5)

• Maximum concentration (Cmax) of HY209

  Up to Day 2

• Ratio of area under curve infinity (AUCinf) of HY209

  Up to Day 2

• Ratio of area under curve last (AUClast) of HY209

  Up to Day 2

• Time of maximum concentration (Tmax) of HY209

  Up to Day 2

• Terminal halif-life (t1/2) of HY209

  Up to Day 2

Study Arms (6)

Cohort 1

EXPERIMENTAL

Single dose of HY209 0.1 mg/kg or placebo.

Drug: HY209

Cohort 2

EXPERIMENTAL

Single dose of HY209 0.2 mg/kg or placebo.

Drug: HY209

Cohort 3

EXPERIMENTAL

Single dose of HY209 0.4 mg/kg or placebo.

Drug: HY209

Cohort 4

EXPERIMENTAL

Single dose of HY209 0.8 mg/kg or placebo.

Drug: HY209

Cohort 5

EXPERIMENTAL

Single dose of HY209 1.6 mg/kg or placebo.

Drug: HY209

Cohort 6

EXPERIMENTAL

Single dose of HY209 3.2 mg/kg or placebo.

Drug: HY209

Interventions

HY209 DRUG

6 Subjects will be assigned to drug (HY209) and 2 subjects will be assigned to placebo.

Also known as: HY209-IV

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5; Cohort 6

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shaperon: lead

Study Sites (1)

Seoul National University Hospital

Seoul, Jongno-gu, 03080, South Korea

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• In-jin Jang

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, placebo-controlled single dosing, dose escalation

Study Record Dates

• First Submitted: February 3, 2020
• First Posted: February 5, 2020
• Study Start: December 5, 2019
• Primary Completion: June 12, 2020
• Study Completion: June 12, 2020
• Last Updated: November 30, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)