A Study of HY209 in Healthy Male Volunteers for Sepsis

Shaperon

Status and phase: Completed; Phase 1

Conditions: Sepsis

Treatments: Drug: HY209

Study type: Interventional

Funder types: Industry

Identifiers

NCT04255979

HY209-IV

Details and patient eligibility

About

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

Full 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).

Enrollment: 40 patients

Sex: Male

Ages: 19 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 6 patient groups

Cohort 1

Experimental group

Description:

Single dose of HY209 0.1 mg/kg or placebo.

Treatment:

Drug: HY209

Cohort 2

Experimental group

Description:

Single dose of HY209 0.2 mg/kg or placebo.

Treatment:

Drug: HY209

Cohort 3

Experimental group

Description:

Single dose of HY209 0.4 mg/kg or placebo.

Treatment:

Drug: HY209

Cohort 4

Experimental group

Description:

Single dose of HY209 0.8 mg/kg or placebo.

Treatment:

Drug: HY209

Cohort 5

Experimental group

Description:

Single dose of HY209 1.6 mg/kg or placebo.

Treatment:

Drug: HY209

Cohort 6

Experimental group

Description:

Single dose of HY209 3.2 mg/kg or placebo.

Treatment:

Drug: HY209